Scientific Opinion on the safety and efficacy of Bacillus subtilis PB6 (Bacillus subtilis) as a feed additive for chickens for fattening
2009
(FEEDAP), EFSA Panel on Additives and Products or Substances used in Animal Feed
Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the safety and efficacy of the product Bacillus subtilis PB6 as feed additive for chickens for fattening. Bacillus subtilis PB6 is the trade name for a feed additive based on viable spores of a strain of Bacillus subtilis. It is intended to be used in feed for chickens for fattening at a minimum content of 1 x 107 and a maximum content of 5 x 107 CFU/kg of complete feedingstuff. The active agent was identified as Bacillus subtilis, a species that is considered by EFSA to be suitable for QPS assessment. The sensitivity to antibiotics and the absence of toxigenic potential qualified the strain for QPS status. Consequently the additive is presumed safe for chickens for fattening, the consumer and the environment. The QPS status of the additive is further supported by the results of a tolerance study and several toxicological tests. Evidence was provided that the additive is not a skin/eye irritant and does not induce skin sensitisation. Data on the dusting potential of the additive do not give concerns of sensitisation via respiratory route. The FEEDAP Panel concludes that the additive is safe for users. Three studies made in two European countries were provided to support the efficacy of Bacillus subtilis PB6. A significant improvement in one or more zootechnical parameters (final body weight, feed to gain ratio) was observed in all three studies. Therefore, the FEEDAP Panel considers that evidence of efficacy of Bacillus subtilis PB6 in chickens for fattening has been provided at the minimum recommended dose. The compatibility of Bacillus subtilis PB6 with the coccidiostats decoquinate, diclazuril, salinomycin sodium, narasin/nicarbazin and lasalocid A sodium has been demonstrated.
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