Pharmaceuticals legislation: EurEau welcomes environmental criteria but calls for more control at source and better access to data

EurEau cautiously welcomes the increased environmental ambition introduced by the Commission’s proposal for the revised Pharmaceuticals legislation. While stronger control-at-source measures are needed, the proposal already constitutes a major step in finally bringing the pharmaceutical sector in line with the Zero Pollution objectives of the Green Deal.

The draft Pharmaceuticals Directive and Pharmaceuticals Regulation unveiled by the European Commission offers a more meaningful role for Environmental Risk Assessments (ERAs) in the authorisation process for medicines in the EU, particularly by requiring that environmental risks identified by the ERA be sufficiently addressed before a product is authorised. Furthermore, if risks are expected, ERA’s will have to be conducted for substances authorised before 2005. Regrettably, the proposals do not grant drinking water and wastewater operators full access to ERAs, although they need this information to conduct their own risk assessments.

Moreover, in order to get a full picture of potential impacts on human health and the environment, assessing the risks posed by pharmaceuticals to drinking water and waste water treatment processes should be made an integral part of the ERA.

We also welcome the ban of over-the-counter sales for products containing substances among the most harmful categories (PBT, vPvB, PMT, vPvM), although this essential control-at-source measure should apply to additional substances in order to bring coherence with the revised Environmental Quality Standards Directive (EQSD).

Pharmaceuticals, when released to the aquatic environment, can pose risks to nature and public health. The European Commission therefore proposed new requirements for many Urban Wastewater Treatment Plants to remove 80% of these substances.