EU wastewater directive's extended producer responsibility challenged
An Advocate General at the EU Court of Justice has proposed that key provisions of the EU's wastewater directive on extended producer responsibility for pharmaceuticals and cosmetics be declared void.
Key provisions within the EU's new wastewater directive concerning extended producer responsibility (EPR) for pharmaceuticals and cosmetics have been challenged, with Advocate General Juliane Kokott proposing their annulment. In her conclusions presented on September 3, 2026, Kokott recommended that Article 9 and Annex III of Directive (EU) 2024/3019 be declared void.
The directive mandates that manufacturers of pharmaceuticals and cosmetics bear at least 80 percent of the costs associated with an additional fourth treatment stage for municipal wastewater, aimed at removing micropollutants. Poland has brought a case against these provisions before the European Union Court of Justice.
According to the Advocate General, there are significant doubts regarding whether the EU legislator adequately established and substantiated the basis for this cost allocation. While acknowledging that pharmaceuticals and cosmetics contribute to micropollutants in wastewater, Kokott noted that the data used during the legislative process lacked transparency and contained considerable uncertainties. The proposal also questions why other sources of micropollutants, such as pesticides and plastic additives, were not included in the EPR scheme.
Pharma Deutschland e.V. has long criticized the EPR regulation, citing its substantial burden on the industry and potential impact on patient supply security. The organization supports the challenge, emphasizing that the legal basis for assigning such significant financial responsibility requires robust scientific and economic justification. The Advocate General's conclusions provide significant legal guidance, although the EU Court of Justice is not bound by them.