The European Medicines Agency (EMA) has published a new guideline for ERA of pharmaceuticals which is effective from September 1st 2024. While in-silico tools may currently help for screening purposes, environmental data will be needed for market approval of new pharmaceuticals, and of existing authorisations or authorisations due for renewal if there is an anticipated increase in the environmental exposure. Unsurprisingly, this topic was frequently raised by delegates who visited us at the CEA booth during EUROTOX2024. How pharmaceuticals have emerged as concerning environmental pollutants is explained below.
Research on passive samplers over the last two decades has shown the presence of pharmaceuticals and other previously-undetected pollutants in surface waters across Europe (Altenburger et al., 2019; Kanwischer et al., 2022). Passive samplers, through accumulation of chemicals over time, provide a quantifiable time-weighted average concentration for each pollutant. In comparison, grab (spot) sampling is the preferred method and provides an actual concentration of the chemical (at the time of sampling) only when the concentration is above their limit of quantification. But when the actual concentration of the pollutant present in a grab sample is lower that the limit of detection and/or quantification, it is not possible to risk assess the known unknowns (chemicals which can be detected but cannot be quantified by grab sampling) and unknown unknowns (substances which are present at low enough concentrations to evade detection altogether by grab sampling). For these two categories, passive sampling has provided a means to detect and quantify (albeit time-weighted average concentrations rather than actual amounts) following accumulation of the pollutants over time (days or weeks).
Pharmaceuticals, either undetected or detected but not quantified by grab sampling, have been found in passive samplers across European surface waters and elsewhere. Furthermore, based on the estimated concentrations from passive sampling, it is understood that waste-water treatment plants removal of pharmaceuticals and other pollutants is considerable but – crucially – not complete. Therefore, there have been increasing concerns of the potential risk to the environment posed by polluting pharmaceuticals – and CEA is perfectly-placed to address these.
CEA specialises in chemical risk assessment for the environment (and for human health); exposure and spatial modelling; aquatic ecotoxicity testing (laboratory and mesocosm studies); and ecotoxicology (terrestrial and aquatic). We provide chemical regulatory support using non-standard approaches to toxicology or ecotoxicity testing, alternative testing approaches, non-standard exposure modelling and risk assessments.
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