Seven organisations present a technical report supporting the need to review the implementation of the Urban Wastewater Treatment Directive

Monday, 21 September 2026, Madrid, Spain. – AELMHU, AESEG, anefp, AseBio, BioSim, Farmaindustria and STANPA, national representatives of the human medicines and cosmetics sectors, present the report prepared together with PwC on the impact and new regulatory, economic and operational challenges arising from Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment, at a time of growing European debate over the implementation of the Extended Producer Responsibility (EPR) scheme established by the legislation.

The report, the result of more than a year of work by the seven associations in coordination with PwC, analyses the implications of the Directive, which raises the requirements applicable to urban wastewater treatment and introduces a new EPR scheme for human medicines and cosmetic products.

The Directive establishes the progressive implementation of quaternary treatment designed to remove micropollutants from urban wastewater and, through EPR, transfers at least 80% of the costs of this treatment to manufacturers of human medicines and cosmetic products. Spain must transpose the Directive by 31 July 2027 and have the EPR scheme in place by 31 December 2028.

The presentation of the report comes as the European debate on the EPR scheme provided for in the Directive remains ongoing. On 18 June 2026, the European Parliament adopted a motion calling on the European Commission to commission a new independent study to identify the micropollutants present in urban wastewater, verify the costs of quaternary treatment and analyse the proper allocation of responsibilities in accordance with the “polluter pays” principle.

This debate is further informed by the conclusions presented on 3 September by Advocate General of the Court of Justice of the European Union Juliane Kokott in Case C-193/25, Republic of Poland v European Parliament and Council. In her conclusions, she recommends that the Court annul the provisions of the Directive requiring manufacturers of human medicines and cosmetic products to finance at least 80% of the costs of quaternary treatment.

In her conclusions, she questions, among other aspects, whether the selection of these two sectors is sufficiently justified and the methodology used to attribute the majority of the toxic burden to them. She also identifies issues related to the “polluter pays” principle, equal treatment and proportionality, in line with some of the shortcomings identified in the PwC report.

Although the Advocate General’s conclusions are not binding on the Court and the Directive remains fully in force until a judgment is issued, this new context reinforces the need to address its transposition with the prudence and legal caution highlighted in the report.

Regulatory, Technical and Economic Uncertainties

The analysis identifies significant uncertainties surrounding the design and implementation of EPR which, according to the report’s conclusions, make it impossible to determine precisely how exemption criteria will be applied, as well as the actual scope of the obligations and their costs. These include determining which substances must be taken into account, the criteria for assessing their hazardousness, the conditions for exemptions and the definition of risk areas.

The application of these criteria will be particularly relevant in determining which products fall under the new scheme. The Directive provides for exemptions for products whose substances are rapidly biodegradable, do not generate micropollutants in wastewater at the end of their useful life or qualify based on the quantities placed on the market, although it does not specify in detail how these criteria should be applied. The Directive also establishes that Member States must take into account the need to ensure the availability, accessibility and affordability of medicines, without specifying how this principle should be implemented within the new scheme.

In addition, the report considers that the exclusive allocation of EPR to human medicines and cosmetic products is based on a methodology involving significant uncertainties, including the absence of fully reliable data on the relative contribution of each sector to micropollution and the use of modelling rather than empirical data in certain analyses.

The report therefore concludes that the implementation of quaternary treatment presents significant technical and economic challenges, particularly in a context of limited experience in Spain. It also highlights the need for the transposition process to provide clarity and legal certainty, and to define precisely the obligations and eligible costs.

A Proportionate, Balanced and Legally Sound Transposition

AELMHU, AESEG, anefp, AseBio, BioSim, Farmaindustria and STANPA fully share the environmental objective of the Directive and its aim of improving the quality of urban wastewater and tackling micropollution more effectively, as outlined in the joint statement published last July. However, the seven associations consider that the EPR scheme, as currently designed, violates the “polluter pays” principle and is contrary to the principles of proportionality and non-discrimination.

For this reason, the associations consider that the Spanish transposition will be decisive in ensuring a proportionate, balanced and legally sound implementation. Among other issues, they argue that the costs charged to manufacturers should be linked to a real, measurable, verifiable and audited service, and that activities unrelated to quaternary treatment should not be passed on to them.

In view of the existing legal, technical and methodological uncertainties, the seven associations advocate a prudent transposition and a flexible, reviewable and legally robust model capable of adapting to developments in the European framework, the available scientific evidence and the results of the system’s own implementation.

The objective, the seven associations emphasise, should be to advance the protection of water resources and the reduction of micropollutants without imposing disproportionate burdens on specific sectors or compromising the sustainability and access to medicines.