Upcoming Pharma legislation must connect milestones of EPR in UWWTD with new CLP amendment

In the recast proposal of the EU Urban Wastewater Treatment Directive (UWWTD) published in October 2022 by the European Commission, an Extended Producer Responsibility (EPR) was proposed for medicinal products for human use and cosmetic products. These two product groups were chosen as they represent the main sources of micropollutants found in urban wastewater requiring additional (quaternary) treatment. The EPR system obligates producers (including importers) to cover monitoring and quaternary treatment costs if they place medicinal and cosmetic products on the national market which pollute urban wastewater with micropollutants above two tonnes per year. The financial
contribution of each producer will be established based on the quantities and toxicity of
micropollutants found in wastewaters.

On the 29th of March 2023, the European Commission postponed its proposal for the revision
of the EU general pharmaceuticals legislation for the second time. However, the introduction
of hazard classes for persistent, mobile and toxic (PMT) and very persistent and very mobile
(vPvM) substances into the Classification, Labelling and Packaging (CLP) Regulation, will go
ahead. The steps forward made by the CLP Regulation, the UWWTD and its long-awaited EPR,
can be further strengthened when the “pharmaceuticals in the environment” approach is
properly implemented. By applying the polluter pays principle correctly, costs of
environmental damage caused by pollution are covered by profits made from such pollution.

In its Special Report 12/2021, the European Court of Auditors made the importance of
allocating costs to producers (and importers) to implement the polluter pays principle clear:
“By applying the Polluter Pays Principle (PPP), polluters are incentivised to avoid environmental
damage.” The question, however, becomes how can pollution be tackled at its source?

“European Union legislation now needs coherence between the UWWTD, pharmaceutical
legislation and the amended CLP Regulation: In extended Environmental Risk Assessments
(ERAs) as part of the authorisation, PMT/vPvM criteria according to the CLP Regulation have to
be included”, Prof. Dr. Matthias Maier, IAWR President points out. “To protect the environment
and human health we need a development towards ‘safe and sustainable by design’ chemicals
and pharmaceuticals. Here, the ZeroPM approach can lead the way.”

ZeroPM co-coordinator Sarah Hale explains: “ZeroPM will interlink prevention, prioritization
and removal strategies to protect the environment and human health from persistent and
mobile substances. Persistent and mobile substances do not break down over appreciable time
scales and can travel long distances with water. This – in combination with the fact that they
are difficult to remove using common water treatment technologies – means that advanced,
and thus costly, treatment methods are required. There are many persistent and mobile
substances that are used in medicinal products and cosmetics.”

Coherence in legislation is strongly needed to tackle the increasing trend of organofluorinecontaining pharmaceuticals. Like PFAS, these chemicals contain the extremely strong carbonfluorine bond that does not degrade naturally. The presence of a CF3 group is considered to improve the performance of the medication but can also lead to the formation of the persistent degradation products including the extremely persistent and ubiquitous trifluoroacetic acid (TFA). Rising TFA concentrations in the environment are already evident.

Emma Schymanski, ZeroPM partner from the University of Luxembourg states that “Of the
19,118 pharmaceuticals in PubChem, 1,801 are organofluorine, of which 800 are PFAS and 669
contain CF3.” ZeroPM co-coordinator Hans Peter Arp adds “We call for a comprehensive
alternatives assessment for these pharmaceuticals that are PFAS, and also a phase-out if their
use is not critical for the functioning of society or where there is an acceptable, safer
alternative available.”