Systematic Assessment of Pharmaceuticals in the Environment, with a Focus on Antibiotics, Endocrine Disrupters and Mixture Effects (SysPIE)

We need pragmatically useful approaches for ranking the ~90% of pharmaceuticals that are as yet uncharacterized for their environmental risks.

SysPIE will, for the first time, systematically collect the evidence for all the antibiotics and endocrine-active pharmaceuticals on the whole EU market and will employ advanced in-silico and read-across tools to provide realistic environmental risk assessments. It will work in close tandem with the recently funded EU project PREMIER.

PREMIER implements a similar approach, but excludes antibiotics and endocrine-active pharmaceuticals from its assessment, despite those 2 classes being most relevant from a risk perspective.

SysPIE will fill this gap.Based on the assessment of the individual pharmaceuticals, SysPIE will then implement a state-of-the-art mixture risk assessment that takes synergistic interactions into account.

This will not only provide a realistic assessment of the environmental impact of pharmaceuticals as a group, but will also determine how important pharmaceuticals are as environmental pollutants, in comparison to other chemicals, e.g. pesticides or biocides.Finally, SysPIE will evaluate the regulatory implication of its findings with respect to (a) the possibility to set sufficiently protective cut-off values (“action limits”) also for antibiotics and endocrine-active pharmaceuticals, (b) the need to apply an additional mixture allocation factor, (c) the suitability of the current regulatory biotesting strategy.