Regulatory approach on environmental risk assessment. Risk management recommendations, reasonable and prudent alternatives.

Current knowledge shows that residues of human medicinal products at trace quantities are widespread in aquatic systems. The sewage treatment plants are pointed out as the major source discharge of these compounds on the environment. In this context, it has been worldwide recognised that the environmental impact of medicinal products have to be evaluated, according to recent EU legislation and regulatory guidance. The strategy of the global risk assessment includes primarily a pre-screening based on the estimation of exposure concentrations of drugs in the wastewater. The present paper addresses the decision-maker frontier of the ecologically relevant endpoints. Risk management recommendation and reasonable and prudent alternatives are discussed to minimise the possible environmental impact.