sentence: The following conclusions are derived.The uses of Bacillus thuringiensis subsp. kurstaki strain PB 54 according to the representative uses as an insecticide on stone fruit and ornamentals ( field uses ) and tomato ( field , permanent greenhouse and walk ‐ in tunnel uses ) , as proposed at EU level result in a sufficient insecticidal efficacy against the target lepidopteran pests.The assessment of the data package revealed no issues that could not be finalised or that need to be included as critical areas of concern with respect to identity , biological properties of the active substance and physical and technical properties of the representative formulation.With respect to mammalian toxicology , two data gaps were identified , the first one concerning the potential adverse effects from repeated inhalation of Bacillus thuringiensis subsp. kurstaki strain PB 54 and the second one related to the potential genotoxic effect of Cry proteins through non ‐ dietary exposure .