Brussels, 12 March 2025 – The Association of the European Self-Care Industry (AESGP) expresses serious concerns over the recently adopted Urban Waste Water Treatment Directive (UWWTD). A key provision of the Directive introduces a new Extended Producer Responsibility (EPR) system. While AESGP recognises the principle of EPR, its selective application – targeting only human medicines and cosmetic products in urban wastewater – is deeply concerning and discriminatory. Under this framework, these two sectors are made responsible for financing the setting up and running of quaternary urban wastewater treatment to remove all micropollutants, regardless of the source of pollution.

Throughout the legislative process, AESGP has repeatedly raised concerns about the lack of conclusive evidence supporting this approach and about the flawed impact assessment that gravely underestimated implementation costs. Furthermore, the Directive’s provisions may arguably breach general principles of EU law, such as the principles of proportionality, legal certainty, and the “polluter-pays” principle.

AESGP is not alone in its concerns about the EPR system proposed in the UWWTD. We acknowledge that Cosmetics Europe, EFPIA and a number of generic medicines manufacturers have challenged the Directive before the EU General Court. We are looking at ways to support their legal actions in order to address the Directive’s shortcomings and ensure a fair and proportionate implementation that aligns with EU legal principles.

Disproportionate, Arbitrary Cost Allocation

The Directive mandates that the pharmaceutical and cosmetics industries cover “at least” 80% of the full cost of quaternary wastewater treatment, despite these sectors contributing to only a fraction of the micropollutants being removed.

The European Commission’s own Feasibility Study, deriving from Joint Research Centre (JRC) datasets, acknowledges the difficulty in directly linking specific product sources to micropollutant concentrations in wastewater due to insufficient data. Another point that is usually made in scientific publications is on the choice of substances detected as being “proxy” substances. This means that these substances, like pharmaceuticals, are merely chosen for being well-known and having standardized detection techniques. These substances act as indicators of the quality of water but are not, by any means, the only substances involved in micro-pollution.

Other substances cited in water quality studies as micropollutants, and contaminants of emerging concern are:

• Pesticides (Rodenticides, Insecticides, Herbicides, Fungicides)
• Biocides (Surface disinfectant)
• Household products (Surfactants/Detergents)
• Fragrances
• PFAS (fire extinguishing, flame retardants and impregnating products)
• Lifestyle drugs (Nicotine, Caffeine – non-pharmaceutical)
• Microplastics and Engineered Nanoparticles (polymers, colorants and surface UV protectors, tyre particles)
• Heavy metals
• Industrial reagents and solvents (estimation of industrial activity still linked to UWWTD 20-60%)
• Pathogens, Hormones, Illegal drugs (Untraceable responsibility)

The EPR scheme, therefore, lacks a scientifically sound basis and unfairly burdens only two industries.

Micropollutants detected in urban wastewaters can originate from multiple sources, attributable to many producing sectors (e.g., caffeine) or not traceable to a source at all (e.g. cocaine). Singling out pharmaceuticals and cosmetics while exempting other contributing industries is unjustified and contradicts the polluter-pays principle. A balanced, evidence-based approach is necessary to ensure that all responsible sectors contribute fairly and that there are no free-riders.

By placing the financial responsibility on two industries, the Directive also fails to incentivize greener product development across all polluting sectors. This undermines not only the polluter-pays principle, as the one implemented through an EPR system, but also the broader goals of the European Green Deal. Moreover, in the pharmaceutical sector, the research and development of new active ingredients takes an average of 13 years, meaning any meaningful shift towards alternative substances would take decades. As a result, the EPR system, as designed, is ineffective in driving environmental innovation for human pharmaceuticals.

As Member States now assess the financial implications, they are finding that actual costs of implementing quaternary treatment are three to eight times higher than originally projected. This substantial miscalculation will ultimately place a much greater burden on the paying sectors than initially anticipated and may lead to withdrawals of economically challenged medicinal products. It is critical that financial responsibility is distributed fairly across all contributing industries putting micropollutants on the EU market, including a 20% contribution by the public sector, to cover the costs of untraceable micropollutants that EU citizens are using.

AESGP Calls for Fair and Effective Transposition and Implementation

AESGP and its members acknowledge the objectives of the UWWTD and understand the relevance of its effective and efficient implementation. However, the Directive’s current approach, including unclear final costs to be borne by two industries, risks undermining patient access to medicines and weakening the global competitiveness of the pharmaceutical sector through rising costs.

AESGP calls on the EU and national authorities to ensure that all substances contributing to pollution by micropollutants are included when the directive is transposed into national law, so that all individual contributors to these substances start contributing at the same time as the pharmaceutical and cosmetics industries.

In addition, AESGP calls on Member States to co-contribute with 20% to the establishment of quaternary water treatment to cover for the costs of non-traceable micropollutants, as foreseen in the Directive. A proportionate and fair approach is essential to effectively address water pollution, while maintaining the competitiveness of the pharmaceutical industry and its ability to supply affordable medicines.

Jurate Svarcaite, AESGP Director General, said: “Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation. Important questions about the real EPR system’s costs, as well as contribution of other industries, remain unanswered. AESGP will be supporting legal action brought forward by other stakeholders by an intervention to ensure a fair and proportionate implementation of this Directive.”