Madrid, July 2 of 2026.

• Aelmhu, Aeseg, Anefp, AseBio, BioSim, Farmaindustria and Stanpa share the environmental objective of the regulations, but we believe that the proposed extended producer responsibility regime violates the polluter pays principle and is contrary to the principles of proportionality and non-discrimination

Improving the quality of urban wastewater is aligned with our commitment to sustainability, environmental protection, and public health—essential pillars of our business. Therefore, the Spanish associations in the pharmaceutical and cosmetics sectors fully share the environmental objective behind Directive (EU) 2024/3019, which entered into force in January 2025 and aims to modernize urban wastewater treatment plants to more effectively combat micro-pollution. In this context, the Ministry for Ecological Transition and the Demographic Challenge concluded the public consultation on the draft bill to transpose the aforementioned Directive into Spanish law last Friday.

Given the importance we attach to this environmental commitment, both sectors appeal to the responsibility of European and national public administrations to properly regulate something on which the future of this fundamental resource for our society directly depends.

For this reason, the seven associations: Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (Aelmhu), Spanish Association of Generic Medicines (Aeseg), Association for Self-Care in Health (anefp), Spanish Association of Bio-enterprises (AseBio), Spanish Association of Biosimilar Medicines (biosimNational Business Association of the Pharmaceutical Industry (Pharmaceutical Industry)) and the National Association of Perfumery and Cosmetics (StanpaWe wish to state that, while we fully share the objective of the new Directive, we are concerned about the specific design of the extended producer responsibility (EPR) system for certain sectors. As currently structured, this system introduces a high level of regulatory, technical, and economic uncertainty, making it difficult to anticipate its actual impact on companies.

In fact, there is a context of legal uncertainty in the European sphere that reinforces the need for regulatory prudence with this Directive: Poland has recently filed an appeal with the CJEU and the High Court of Ireland raised, in May 2026, a preliminary question on the validity of the RAP regime.

In that context, the associations commissioned a technical and legal report from the consulting firm PwC in relation to the Directive, its regulatory scope and the costs involved.

Based on the analysis carried out, the seven associations express the following common considerations:

1. Extended producer responsibility (EPR), as currently designed, violates the polluter pays principle and is contrary to the principles of proportionality and non-discrimination:

The RAP scheme is based on the flawed premise that the human pharmaceutical and cosmetics sectors are the primary contributors to the toxic load of urban wastewater. Despite available evidence, the directive suffers from significant methodological limitations, a lack of robust empirical evidence, the use of biased models, an absence of comprehensive data on actual contributions, and difficulty in establishing a sufficient causal link, thus calling into question the proportionality and proper application of the "polluter pays" principle.

All these limitations have resulted in substances being overlooked and equally polluting sectors being excluded.

Proof of this is that on June 18, 2026, the European Parliament itself approved a motion through which it addresses a request to the European Commission to carry out, before the end of 2026, a new independent study to identify the micro-pollutants present in urban wastewater, verify the costs associated with quaternary treatment given the evident divergences between the different estimates made, as well as the correct attribution of responsibilities to the relevant sectors in accordance with the principle of "the polluter pays".

National transposition will be crucial to ensuring a proportionate, balanced, and legally sound application of the new regime. In this regard, the explanatory memorandum of the regulation acknowledges that Member States may go beyond the minimum requirements, in line with Article 193 of the Treaty on the Functioning of the European Union. Therefore, the transposition should take advantage of this leeway to extend the RAP (Regulatory Action Plan) to other sectors, preventing the burden from falling disproportionately on the pharmaceutical and cosmetic sectors alone.

2. Uncertainties prevent a precise determination of the application of the exemption criteria, as well as the actual scope of the obligations and their costs.

The lack of clearly defined risk zones and methodological differences between impact studies make it difficult to identify both the scope and the true economic impact. Consequently, estimated costs vary widely, from €134 million per year to €346 million per year in 20-year projections, which would represent costs of between €2.680 billion and €6.920 billion. Furthermore, the exemption criteria for substances included in the Extended Producer Responsibility (EPR) scheme are still pending development, an aspect that is particularly relevant for the establishment of the Collective Extended Producer Responsibility (EPR) system.

Therefore, the implementation of the RAP should be postponed until these uncertainties are resolved.

3. The implementation of quaternary treatment presents significant technical and economic challenges in a context of still limited experience in Spain.

Spain starts from a situation of significant non-compliance in the treatment of urban wastewater, with several and even recent condemnations by the Court of Justice of the European Union.

While primary and secondary treatments are widespread in Spain, tertiary treatments are limited and quaternary treatments are concentrated in pilot projects, as well as in a very small number of plants.

In this regard, the allocation of costs to producers should be conditional upon the existence of a real, measurable, verifiable, and audited service. Contributions for quaternary treatment operating costs should not be required until the facilities are fully operational and their efficient functioning, performance, and net cost have been certified. Regarding investment costs, any advance contribution should be linked to approved plans, verifiable milestones, independent auditing, final traceability, and mechanisms for adjustment, compensation, or reimbursement if the infrastructure does not become operational, fails to achieve the expected performance, or if the actual costs are lower.

Furthermore, producers should not be charged costs related to other actions unrelated to quaternary treatment, such as those aimed at water reuse.

4. The transposition must strictly adhere to the mandatory framework of the Directive, avoiding unjustified additional costs and ensuring balanced funding.

The Spanish transposition should limit producers' contributions to the minimum required by the Directive, that is, 80% of eligible costs, avoiding any over-regulation that would increase this contribution. The remaining percentage should be publicly financed, given the public nature of sanitation, the multi-source origin of micropollutants, and the general interest associated with protecting water and public health.

5. The European debate surrounding the RAP regime suggests a prudent and legally cautious transposition.

It is considered appropriate that the Ministry take into account the existence of legal and technical debates at the European level regarding the scope, proportionality and design of the RAP provided for in the Directive, as well as its fit with the principles of equal treatment and the polluter pays, without prejudging its outcome in any case.

This situation suggests that Spain should establish a flexible, revisable, and legally sound system, capable of adapting to potential judicial rulings, European guidelines, methodological changes, or adjustments arising from the evolution of the European framework and the practical implementation of the system itself. In this context, the Spanish transposition should avoid rigid or maximalist options and include mechanisms for automatic review or adaptation in the event of significant changes in the European legal framework, cost methodology, the availability of scientific data, or the results of the system's implementation.