One of the aims of the PREMIER project is to develop a framework to prioritise the environmental assessment of existing Active Pharmaceutical Ingredients (APIs). The prioritisation of APIs will follow a risk-based approach, where the predicted exposure concentration (PEC) is combined with an effect-based threshold (ETH), often represented by the Predicted No-Effect Concentration (PNEC). We aim to identify APIs that are suspected to cause a high risk, but for which an unambiguous conclusion cannot be drawn because of lacking data. In order to prioritize these APIs, several types of data are needed.
The purpose of this call is to offer interested parties (PREMIER partners, national authorities, universities, research institutions, companies, interested organizations) the opportunity to submit or suggest relevant data sources (e.g., databases and literature sources) for the prioritization of APIs. In particular, we are looking for data sources containing the following information:
- Sales and consumption data of pharmaceuticals at national or regional level;
- The fraction of the administered dose that is excreted by humans as the parent drug (urinary and faecal excretion);
- Removal efficiency of APIs in WWTPs (wastewater removal);
- Bioaccumulation data, such as bioconcentration factors (BCFs) in fish;
- Pharmacokinetic parameters (such as Cmax or Css) indicating the therapeutic concentration in humans.
We invite all the interested parties who wish to provide a relevant input, to send the available information to email@example.com by the 31 December2021.