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Safety and efficacy of Bactocell PA (Pediococcus acidilactici CNCM MA 18/5M) for pigs for fattening, minor porcine species, chickens for fattening and minor avian species


Panel members at the time of adoption

Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester


Bactocell PA is the trade name for formulations of feed additives based on viable cells of a strain of Pediococcus acidilactici. This opinion concerns the re-evaluation of the use of the additives in feed for pigs and chickens for fattening and a new application for use with minor porcine and avian species. Pediococcus acidilactici is considered by EFSA to be suitable for the qualified presumption of safety approach to establishing safety. As the identity of the active agent was established and its susceptibility to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, including minor porcine and avian species, consumers and the environment. Bactocell PA is non-irritant to skin and eyes and is not a dermal sensitiser. The presence of particles of respirable size and the proteinaceous nature of the additive indicates a risk of respiratory sensitisation. Data from the individual trials provides evidence that the inclusion of Bactocell PA at a dose of 1 × 109 colony-forming unit (CFU)/kg complete feed (5 × 108 CFU/L if delivered via water for drinking) has the potential to improve the performance of pigs for fattening and chickens for fattening. Previous opinions have established efficacy for weaned piglets and for laying hens at the same dose. As the mechanism of action of the additive can be reasonably assumed to be the same, efficacy for minor avian and porcine species can be presumed when used at the same dose. Therefore, Bactocell PA can also be considered efficacious for minor avian species (fattening and laying) and minor porcine species (weaned and for fattening) at a dose of 1 × 109 CFU/kg feed (5 × 108 CFU/L if delivered via water for drinking). Pediococcus acidilactici is compatible with the coccidiostats halofuginone, diclazuril, decoquinate and nicarbazin.

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