Safety and efficacy of microorganism DSM 11798 as a technological additive for all avian species

Abstract Biomin® BBSH 797 is the trade name for a feed additive containing viable cells of an unnamed bacterium (DSM 11798). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) produced an opinion on the safety and efficacy of this additive when used with pigs concluding that the additive itself did not raise any safety concern. It was confirmed that the additive could reduce the trichothecene, deoxynivalenol (DON), producing the less toxic de‐epoxy metabolite. The applicant is now seeking authorisation for the use of the additive in feed for all avian species and, since the current authorisation only covers DON, the amending of this authorisation to include all trichothecene mycotoxins. Chickens and turkeys for fattening and laying hens showed no adverse effects when the additive was added to diets at 1000 times the recommended dose. Consequently, the additive is considered safe for these species/categories when used at the recommended dose of 1.7 × 108 colony‐forming units (CFU)/kg complete feed. This conclusion is extended to all avian species. The use of the additive in feed for all avian species is not expected to introduce concerns for consumers, users or the environment not previously considered. In vitro and in vivo studies showed that the inclusion of the additive at the recommended dose of 1.7 × 108 CFU/kg was effective in reducing contaminating DON in feed when given to avian species with a concomitant production of the less toxic de‐epoxy metabolite. The additive was shown to reduce the 12,13‐epoxide group of representative trichothecenes. It would be reasonable to assume a similar reaction with other mycotoxins of the same structural type independent of the animal species or category receiving contaminated feed. The additive is compatible with the coccidiostats monensin sodium, salinomycin sodium, narasin, narasin/nicarbazin, nicarbazin, robenidine hydrochloride and diclazuril.

[1]  W. Shier,et al.  Cytotoxicity and phytotoxicity of trichothecene mycotoxins produced by Fusarium spp. , 2013, Toxicon : official journal of the International Society on Toxinology.

[2]  S. Bursian,et al.  Peptide YY3-36 and 5-hydroxytryptamine mediate emesis induction by trichothecene deoxynivalenol (vomitoxin). , 2013, Toxicological sciences : an official journal of the Society of Toxicology.

[3]  R. Resanović,et al.  Efficacy of T-2 toxin detoxifying agent in broiler chickens. , 2012 .

[4]  V. Dohnal,et al.  Metabolic pathways of trichothecenes. , 2009, Drug metabolism reviews.

[5]  A. Chesson,et al.  Safety and efficacy of STENOROL (halofuginone hydrobromide) as a feed additive for chickens for fattening and turkeys , 2009 .

[6]  G. Diaz,et al.  Evaluation of the Efficacy of Four Feed Additives Against the Adverse Effects of T-2 Toxin in Growing Broiler Chickens , 2005 .

[7]  H. Humpf,et al.  Structural elucidation and analysis of thermal degradation products of the Fusarium mycotoxin nivalenol. , 2005, Molecular nutrition & food research.

[8]  G. Eriksen,et al.  Comparative cytotoxicity of deoxynivalenol, nivalenol, their acetylated derivatives and de-epoxy metabolites. , 2004, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[9]  G. Díaz.  Evaluation of the efficacy of a feed additive to ameliorate the toxic effects of 4,15-diacetoxiscirpenol in growing chicks. , 2002, Poultry science.

[10]  R. Krska,et al.  Structural characterization of metabolites after the microbial degradation of type A trichothecenes by the bacterial strain BBSH 797 , 2002, Food additives and contaminants.