a) the residual risk exceeds the manufacturer’s criterion for risk acceptability;b) the residual risk is acceptable because it is so small as to be negligibleorc) the residual risk is between the two states specified in a) and b); for these risks the residual risk isacceptable for the option that reduces the risk to the lowest practicable level, bearing in mind the benefitsresulting from its acceptance and taking into account the costs of any further reduction.