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Gaps in the UWWTD Extended Producer Responsibility (EPR)

The Attribution Problem: Scientific Evidence and how I will help you tackle this

Dr. Ana de Almeida, PhD
Scientific Strategist & Project Coordinator | 22 Years Water Quality Research

The revised Urban Wastewater Treatment Directive (EU 2024/3019) introduces an Extended Producer Responsibility (EPR) mechanism. This is necessary as many locations in Europe still need better wastewater treatment access.

The EPR fees will require both pharmaceutical and cosmetics manufacturers to fund at least 80% of Quaternary treatment costs. This funding allocation derives from the Commission’s impact assessment. But a critical evidence gap remains. This gap creates both regulatory risk and opportunity for companies during the 2025-2027 transposition period.

The Scientific Challenge: Modeling Assumptions vs. Empirical Reality

Pharmaceuticals and personal care products are the most often detected micropollutants, but detection frequency does not equal proportional mass contribution.The distinction between detection frequency and mass contribution shows the foundational scientific challenge.

Determining these comparisons at a facility level is critical for precise EPR transposition.

Systematic literature reviews consistently acknowledge the absence of quantitative sectoral breakdowns. The critical limitation is that most monitoring programmes were designed to detect priority substances. They do not quantify sectoral contributions. This means existing analytical methods cannot yet support robust source attribution.

Questions that are relevant here:

  1. Are these compounds more detected because they are more studied?
  2. Are medicines and cosmetics class of ingredients more studied because they are directly used in humans?
  3. Is the environmental risk assessment of these two classes of ingredients more telling?

The Complexity of Source Attribution and Emerging Discrepancies

The complexity of source attribution comes from multiple factors. The Commission’s impact assessment partially addresses this. This partial address is expected, as data limitations are an inherent challenge every new environmental regulation faces. However, when comprehensive data is unavailable, the critical next step is generating the right facility-specific evidence.

Multi-Sector Application Challenge

Many chemicals have multi-sector applications (e.g., preservatives appearing in cosmetics, pharmaceuticals, industrial processes, and household products), making single-source attribution scientifically problematic without empirical validation.

Non-Linear Environmental Fate

The relationship between market placement volumes and environmental loads is not linear. Substances with high biodegradability have qualities that qualify products for EPR exemptions under Article 9(2). Similarly, substances with strong sorption to sewage sludge qualify for these exemptions. They have high consumption but low aquatic discharge. Persistent compounds contribute disproportionately to effluent loads.

Evidence of Significant Overestimation

The May 2025 disclosure of Joint Research Centre database methodology to Cosmetics Europe revealed important findings. It showed that the cosmetics sector’s toxic load contribution was overestimated by at least fifteen-fold. This overestimation demonstrated fundamental limitations in consumption-based modeling approaches without empirical validation.

The Reality: Independent facility-specific analysis is necessary to bridge the Commission’s Europe-wide methodology to individual company scenarios. The regulatory body lacks resources to conduct this granular validation for every producer—this is where our consultancy provides essential support.

The Critical Need for Defensible Data

The legal challenges initiated by EFPIA and Cosmetics Europe in March 2025 are underway. They request that courts evaluate whether the Commission’s 92% attribution meets the necessary evidentiary standards. This evaluation is required for proportional liability assignment under the polluter-pays principle (Article 191(2) TFEU).

The scientific central question: Does consumption-based modeling without empirical validation provide sufficient evidence to assign proportional financial responsibility?

Three Urgent Research Questions Remain Unanswered

The scientific literature explicitly identifies critical knowledge gaps:

  1. What is the precise percentage contribution of each industrial sector to micropollutants loads in European wastewater?
  2. How do regional consumption patterns and regulatory differences affect sectoral contributions?
  3. What are the most effective methods for source apportionment of overlapping-use chemicals?

The critical timeline: The period for evidence generation extends through July 2027, when Member States must complete national transposition. Companies can only move beyond contested assumptions through rigorous, facility-specific validation. These steps enable evidence-based cost allocation that protects against over-attribution.

Expert Solution: Defining Your Contribution First

The UWWTD’s EPR represents regulatory sequencing, not regulatory completion. The initial focus is on Pharmaceuticals and Cosmetics. This is pragmatic for rapid framework establishment. It sets the precedent for future evaluations. The scheme will expand to household cleaning products, the textile industry, and industrial chemicals.

A Scientific Validation Blueprint

Dr. Ana de Almeida serves as Lead Scientific Strategist and External Project Coordinator, providing:

  1. Critical Gap Analysis: Identifying your company’s specific data vulnerabilities
  2. Scientific Validation Design: Designing the precise analytical steps needed to validate your actual contribution
  3. Regulatory Translation: Converting technical evidence into defensible regulatory documentation for Member State transposition

The July 2027 transposition deadline drives the need for facility-specific data generation. This is critical during the 2025-2027 window. Pharmaceutical and cosmetics manufacturers require tailored scientific validation strategies.

Ana Almeida, PhD
Regulatory Excellence in Life & Environmental Sciences
[Website] | [LinkedIn] | [Email]

(+39) 346 3709 748, Viterbo, Italy.

REFERENCES

Regulatory Documents

Photo by Pixabay on Pexels.com
  1. European Medicines Agency (EMA). Guideline on the environmental risk assessment of medicinal products for human use – Revision 1. Adopted Reference Number: EMEA/CHMP/SWP/4447/00 Rev. 1 – Corr. Legal effective date: 01/09/2024. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-environmental-risk-assessment-medicinal-products-human-use-revision-1_en.pdf
  2. European Union. Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (recast). Text with EEA relevance PE/85/2024/REV/1. Official Journal of the European Union. Available at: https://eur-lex.europa.eu/eli/dir/2024/3019/oj
  3. European Commission. Answer given by Mr Sinkevičius on behalf of the European Commission. Parliamentary Question E-002784/2023. 7 November 2023. Available at: https://www.europarl.europa.eu/doceo/document/E-9-2023-002784-ASW_EN.pdf

Scientific Studies and Impact Assessments

  1. BioInnovation et al. Study supporting the Impact Assessment for the revision of the Urban Wastewater Treatment Directive. European Commission, 2022. Available at: https://op.europa.eu/en/publication-detail/-/publication/14249cbc-5f1c-11ed-92ed-01aa75ed71a1/language-en

Industry Reports and Position Papers

  1. Medicines for Europe. Note on Bio-Innovation list of substances found in urban wastewater. July 2025. Available at: https://www.medicinesforeurope.com/wp-content/uploads/2025/07/Medicines-for-Europe-note-on-Bio-Innovation-list-of-substances-found-in-urban-wastewater_July2025.pdf
  2. Ramboll. Micropollutants in Urban Wastewater – Report for Medicines for Europe. May 2025. Available at: https://www.medicinesforeurope.com/wp-content/uploads/2025/05/Ramboll-Report_Micropollutants-in-Urban-Wastewater.pdf
  3. Medicines for Europe. Summary for publication on UWWTD EPR impact. May 2025. Available at: https://www.medicinesforeurope.com/wp-content/uploads/2025/06/Summary_for-publication-May-2025.pdf
  4. Medicines for Europe. Case for UWWTD in the simplification omnibus. March 19, 2025. Available at: https://www.medicinesforeurope.com/wp-content/uploads/2025/05/Case-for-UWWTD-in-the-simplification-omnibus-03192025.pdf

KEY LEGAL PROVISIONS CITED

From Directive (EU) 2024/3019 (UWWTD)

DISCLAIMER ON REFERENCES

All website links were verified as accessible as of October 2025. Some documents may require registration or may be subject to access restrictions. For official regulatory guidance, always consult the primary sources at:

Readers should verify all regulatory requirements with official national competent authorities in their respective EU Member States. Implementation may vary by jurisdiction.

Document prepared by: Dr. Ana Carolina Maganha de Almeida, PhD
Version: 2.0
Date: October 2025

Document Version: 2.0 | Date: October 2025 | Status: Under Internal Review

Analysis of critical gaps in the UWWTD Extended Producer Responsibility scheme for pharmaceuticals and cosmetics. Expert regulatory insights from Dr. Ana Almeida.

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