Is the objective of the Water Framework Directive to deal with pollutant emissions at source coherently implemented by the EU's substance-specific legal acts? A comparison of the environmental risk control of pharmaceutical legislation with the REACH-, Biocidal Products- and Plant Protection Products Regulation

The general objectives of the Water Framework Directive (WFD) are achieving good surface water and groundwater status, the reduction of pollution by priority substances and the prevention or limit inputs of pollutants into groundwater, whereby pollutant emissions are to be dealt with at source. The present study shows that these objectives are not coherently implemented by the substance-specific legal acts of the Union. While the three regulatory frameworks for industrial chemicals, biocides and pesticides have implemented instruments such as: - the centralisation and statutory establishment of the environmental risk assessment, - the post-market control of environmental risks, - a programme for old substances not (sufficiently) assessed for environmental risks, - the substitution of environmentally hazardous substances, - the public participation and transparency with regard to the integration of environmental concerns, that help to achieve the environmental objectives and also strengthen the interaction between substance law and environmental protection law through explicit links, the pharmaceutical legislation shows considerable deficits in comparison. Even though the active pharmaceutical ingredient diclofenac will be added to the list of priority substances in the near future, the current instruments of the pharmaceutical legislation will not be able to react at source when a defined environmental quality standard is exceeded. As a result, the legal framework of pharmaceuticals in its current form cannot meet the environmental objectives of the WFD. To create the legal requested coherence between the substance-specific legal acts and the WFD, the instruments listed above can and should be enshrined in the pharmaceutical legislation as well.

Automated summary

The study shows that the objectives of the Water Framework Directive are not consistently implemented by the substance-specific legal acts of the Union. While regulatory frameworks for industrial chemicals, biocides, and pesticides have implemented various instruments to achieve environmental objectives, pharmaceutical legislation is lacking in comparison. This highlights the need to incorporate similar instruments in pharmaceutical legislation to ensure coherence with the Water Framework Directive.