Scientific Opinion on Miya-Gold® (Clostridium butyricum) as a feed additive for weaned piglets, minor weaned porcine species and minor avian species

Miya-Gold® S is a zootechnical additive containing 5 x 10⁸ CFU/g viable spores of Clostridium butyricum. The product is presently authorised in the European Union for use with chickens for fattening. The applicant is now seeking authorisation for the use of Miya-Gold® S with weaned piglets, ‘minor weaned porcine species’ and minor avian species, and of Miya-Gold® EU, a more concentrated formulation. The safety for a major poultry species (chickens for fattening) has been previously established. Given the wide margin of safety observed, safety can be presumed for all minor avian species (other than layers) to a maximum dose of 5 x 10⁸ CFU/kg complete feed. Weaned piglets showed normal growth at 200 times the recommended dose without any adverse effects. Consequently, the FEEDAP Panel concludes that the product is safe for weaned piglets, pigs for fattening and for minor porcine species at the recommended dose of 2.5 x 10⁸ CFU/kg complete feed. The use of the more concentrated formulation Miya-Gold® EU is not expected to introduce hazards for the consumers or the environment not already considered in the previous application nor for the target species. However, the large proportion of particles with diameters < 10 μm found in Miya-Gold® EU may increase the likelihood for respiratory sensitisation of users of the additive. Efficacy at the same dose is unlikely to be measurably affected by the formulation used. Based on the results of a meta-analysis of the results of four trials, the FEEDAP Panel concluded that Miya-Gold® in diets for weaned piglets can improve weight gain and the efficiency of feed conversion. This conclusion can be extrapolated to minor porcine species. As efficacy for chickens for fattening has been previously established, efficacy for minor avian species (other than layers) can be presumed at the same dose without requiring specific studies.