The CJEU has dismissed the action brought by the EFPIA against key provisions of the recast Urban Wastewater Treatment Directive (UWWTD), including the Extended Producer Responsibility (EPR).This confirms that the Member States must apply the UWWTD EPR obligations to these sectors as adopted in November 2024.
The recast UWWTD introduces an Extended Producer Responsibility (EPR) obliges producers of human medicines and cosmetics to contribute financially to the implementation of advanced “quaternary” treatment of urban wastewater, aimed at removing micropollutants not fully captured by conventional treatment processes. Under the Directive, producers are to cover a substantial share of the infrastructure and operational costs associated with quaternary treatment.
The pharma sector appealed to the Cour under the following arguments:
- The Commission’s impact assessment overestimated the contribution of pharmaceuticals to urban wastewater micropollution, resulting in a flawed impact assessment
- That the compliance with the polluter-pays principle, and the fulfilment of the quaternary treatment obligations, would allocate disproportionate costs to the actual contribution of their products to urban wastewater micro pollution.
- The EPR measures are disproportionate to the pharma sector and not necessary to achieve the Directive’s environmental objectives.
- The application of the EPR scheme would be discriminatory, by making the pharma and cosmetics bear the costs arising from pollution caused by other sectors.
- The application of the UWWTD would bring legal uncertainty and would impose unpredictable costs on medicines.
In its judgment, the General Court rejected the action in its entirety, confirming that the contested UWWTD provisions remain valid and must be applied by Member States in accordance with the Directive’s transposition timelines. The dismissal means that Member States must implement the EPR scheme and that pharmaceutical and cosmetic producers will be subject to compliance obligations, including contributions to quaternary wastewater treatment costs, by the statutory deadlines.
Industry stakeholders had previously raised concerns about proportionality, discrimination, polluter-pays compliance, and cost predictability, citing potential impacts on manufacturing and market access. Conversely, water sector organisations have emphasised that the EPR scheme is aligned with broader environmental objectives to mitigate micropollutant loads and protect aquatic ecosystems while shielding water users from tariff increases.
Following entry into force of the recast UWWTD on 1 January 2025, Member States are required to transpose the Directive into national law by 31 July 2027, and EPR obligations will take effect in national scheme implementations by 31 December 2028. With the Court confirming the legal validity of the UWWTD’s EPR scheme, Member States and relevant stakeholders shall continue the transpositions of the Directive.
