News about the environmental classification in the database Environment and Pharmaceuticals
Hazard and risk should be considered when assessing how harmful a pharmaceutical may be to the environment.
The environmental classification of pharmaceuticals in the Environment and Pharmaceuticals database has been updated to be more compatible with the regulatory framework and for increased transparency. Changes in the database are as follows:
- PBT index has been renamed to hazard score. The hazard score is used to assess the environmental harmful properties of a pharmaceutical and includes the ability to resist degradation (P = persistence), ability to accumulate in adipose tissue (B = bioaccumulation) and the potential to poison aquatic organisms (T = toxicity). The reason for the change is that there are PBT/vPvB (Persistent, Bioaccumulative and Toxic/very Persistent and very Bioaccumulative) substances with particular environmental harmful properties according to the European Regulatory Regulations.
- As more and more pharmaceuticals, not least newly approved ones, now have information about chronic toxicity, a classification has been made according to the European Chemicals Guidelines. The environmental assessment document for each pharmaceutical substance in the database, shows whether T refers to acute or chronic toxicity in the hazard score.
- Successively, information about underlying data for P, B and T will be added to the individual pharmaceutical documents because the hazard score is a rough measure. When comparing two pharmaceuticals with the same score, there may be a reason to look more at underlying data.
- For newly approved pharmaceuticals with an Environmental Risk Assessment, ERA, in the European Public Assessment Report (EPAR), information is primarily taken from there. Risk estimates in the ERA have been carried out from a European perspective, while risk from Fass.se refers to the expected concentration of a pharmaceutical in Swedish waters. The documents for individual pharmaceuticals state if the risk concerns a European or a Swedish perspective.
- Information on risk assessments, based on measured levels in the environment and toxic effects, conducted by the environmental consulting company Goodpoint AB in collaboration with Joakim Larsson, Professor of Environmental Pharmacology, are also included in the database. These risk assessments are an important complement to the theoretical risk assessments from EPAR and Fass.se.