knowledge 27 May 2026 |

Is the polluter paying? European challenges to the revised Urban Waste Water Treatment Directive

The Irish Pharmaceutical Healthcare Association and Alliance of Medicines for Ireland CLG has joined a number of other pharmaceutical and cosmetic industry associations across the EU in challenging Directive 2024/3019 concerning the revised Urban Waste Water Treatment Directive (the “Directive”).

On 20 May 2026, Mr Justice Humphreys of the Irish High Court made a request for a preliminary ruling in relation to the interpretation of Articles 9, 10 and Annex III of the Directive. The reference arose in proceedings taken in October 2025 by the Irish Pharmaceutical Healthcare Association Limited, and Alliance of Medicines for Ireland CLG concerning a challenge to the proposed domestic transposition of the Directive into Irish law.

The Directive mandates the progressive introduction into urban wastewater treatment plants of an additional treatment, known as quaternary treatment, for the purposes of removing micropollutants.  The Directive obliges Member States to take measures to ensure that producers who place on the market human medicines and cosmetics cover at least 80% of the costs of complying with this requirement, through an extended producer responsibility (EPR) scheme.

Article 9 of the Directive requires Member States to take measures to ensure that by 31 December 2028, producers who place any of the products listed in Annex III on the market have extended producer responsibility, including that those producers cover at least 80% of the full costs for complying with quaternary treatment.  Article 10 of the Directive sets out minimum requirements for producer responsibility organisations.

A question on the validity of these provisions has been referred to the CJEU in light of Article 168 TFEU (which requires that a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities), and the polluter pays principle under Article 191(2) TFEU, read in light of general principles of EU law including proportionality and equal treatment, non-discrimination, and/or legal certainty.

While the Directive lists products covered by the EPR scheme, member states are free to add more sectors if they find those are also contributing to the micropollutant load. In correspondence exchanged between the Applicants, and the Minister for Housing, Local Government and Heritage, prior to the issue of proceedings, the Minister indicated, amongst other matters, that it was not intended to extend the EPR scheme to other sectors.  It is this decision of the Minister that the Applicants have challenged. The substantive determination of the main proceedings has been adjourned pending the judgment of the CJEU.

European challenges to the Directive

The request for a preliminary ruling follows the dismissal of sixteen legal challenges brought before the General Court of the EU by Cosmetics Europe, the European Federation of Pharmaceutical Industries and Associations and various pharmaceutical companies. These cosmetic and pharmaceutical associations asserted that the blanket imposition of costs on their industries for the operation of quaternary treatment was at a “staggeringly higher amount” than their proportion of contributions to water pollution.

The General Court denied standing for these Applicants in February 2026, determining the provisions were of “general application” with the companies/associations failing to prove they were individually concerned with the contested provisions. Appeal proceedings concerning this refusal are currently before the ECJ.

Subsequent proposals by associations such as Cosmetics Europe to ‘stop the clock’ for the application of EPR have so far been considered but rejected by the EU Commission. However, the EU is under sustained internal pressure to do so with the latest development on 12 May 2026, where a Motion for a Resolution was tabled in the European Parliament calling on the Commission to remove EPR for medicinal products while emphasising that EPR must remain “proportionate and cost-effective”. The Motion is currently awaiting further discussion in the European Parliament.

Next Steps

The Directive entered into force in 2025 and Member States are required to transpose it by 31 July 2027. However, the Directive may not reach this transposition date in its current form in light of the sustained challenges taken by pharmaceutical and cosmetic associations across the EU and from now also from Ireland.

Also contributed to by Adam Crothers