The Court of Justice of the European Union has declared inadmissible a set of appeals filed by companies and associations in the pharmaceutical and cosmetics sectors against the extended producer responsibility (EPR) measures included in the revision of the Urban Waste Water Treatment Directive (UWWTD, 2024/3019).
In orders issued on 18 February, the General Court – the lower of the two bodies that make up the Court of Justice of the European Union – ruled that the applicants had not demonstrated the existence of an individual interest, an essential requirement for challenging a Union legislative act before the European courts. As the directive does not name or directly target the companies involved, the appeals do not meet the conditions for admissibility under EU law.
In a statement, the European Federation of Pharmaceutical Industries and Associations (EFPIA), one of the applicants, reiterated their commitment to upholding the fundamental principles of EU law, such as “polluter pays”, non-discrimination and proportionality, and announced that they would continue to challenge the Urban Waste Water Directive, arguing that its current structure violates these principles.
Appeals against the funding of quaternary treatment
The legal actions, filed in March 2025, targeted the financing mechanism for the new quaternary treatment stage introduced by the directive. The purpose of this additional treatment stage is to remove a wide range of micro-pollutants, including pharmaceutical residues and cosmetic ingredients, from urban wastewater, and it will entail significant additional costs for plant operators.
Industry organisations had questioned both the proportionality of the EPR regime and the European Commission's impact assessment, arguing that the allocation of costs to their sectors was excessive and insufficiently justified. As EFPIA points out: “in parallel, the Irish Pharmaceutical Healthcare Association is progressing its case in the High Court in Ireland, seeking a referral to the Court of Justice of the European Union (CJEU) for a preliminary ruling on the validity of the UWWTD. The General Court’s Order clarifies that national courts should refer such matters to the CJEU if there are doubts regarding a Directive's validity.”
Extended producer responsibility reaches the water sector
In its latest version, published in the Official Journal of the European Union on 12 December 2024, the Urban Waste Water Treatment Directive imposes on manufacturers of pharmaceuticals and cosmetics the obligation to cover at least 80% of the additional costs associated with quaternary treatment. The measure implements the “polluter pays” principle, established in Article 191(2) of the Treaty on the Functioning of the European Union.
According to the Commission, the pharmaceutical and cosmetics sectors are responsible for most of the micro-pollutants detected in urban wastewater. The directive concludes that an EPR system is the most appropriate tool for internalising environmental costs, mitigating the financial impact on consumers and public authorities, and incentivising the development of less polluting products.
UWWTD, the EU's most ambitious framework for wastewater protection
Originally enacted in 1991, the Urban Waste Water Treatment Directive (UWWTD) has been a pillar of European water policy for over thirty years, safeguarding aquatic ecosystems and human health from the impacts of urban discharges. The 2024 version significantly raises the level of ambition, integrating a One Health approach and introducing stricter treatment requirements to tackle emerging pollution.
The revision of the UWWTD entered into force on 1 January 2025. Member States must implement the directive into national law by 31 July 2027, while EPR obligations will become operational at a national level by 31 December 2028.
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