Pharma to Help Fund the Treatment of Micropollutants

Producers of medicinal and cosmetics products will have to pay for the removal of micropollutants from urban wastewater under an amendment to the Urban Wastewater Treatment Directive. Our Planning & Environment team looks at how this might impact producers.

Ireland will be required to establish an extended producer responsibility (EPR) Scheme by 31 December 2028 to fund the enhanced treatment of micropollutants. As part of the Scheme, producers that place certain medicinal or cosmetics products on the Irish market must contribute to the treatment costs. These requirements have been adopted in a revision to the Urban Waste Water Treatment Directive[1] (the Revised Directive). Ireland must transpose the Revised Directive by 31 July 2027.

The EU has targeted the pharmaceutical and cosmetics industries, as it considers that they are the main source of micropollutants in urban wastewater. However, these industries anticipate the costs will be prohibitively and disproportionately expensive. The EU, on the other hand, says the potential increase of costs of products, or the potential reduction of profit margins for producers, will be marginal at EU level. It believes this will not endanger the affordability, availability, or accessibility of these products on the EU market.

Additional pollutants

The Revised Directive extends the scope of the Directive to a greater amount and type of pollutants. It includes:

• Heavy metals
• Microplastics
• Micropollutants, and
• Other chemicals such as per- and polyfluoroalkyl substances (PFAS)

The Recitals to the Revised Directive state that recent scientific evidence highlights PFAS as an environmental and public health concern. Their persistence in the environment contributes significantly to this issue. Understanding the ways in which PFAS can enter the environment is a priority aim of the Revised Directive. To achieve this, Member States will be required to monitor PFAS at the inlet and outlet of waste water treatment plants (WWTPs).

Quaternary treatment

Under the Revised Directive, Ireland will have to apply an additional treatment to certain urban wastewater discharges to meet specified levels for the removal these pollutants. This treatment is known as ‘quaternary treatment’, ie a process which reduces a broad spectrum of micropollutants in urban wastewater.

The EU has prescribed the targets on the basis of the “precautionary principle” in combination with a risk-based approach. The targets to be achieved for urban WWTPs having a load of at least 150,000 population equivalent are as follows:

• 31 December 2033 for discharges from 20% of those urban wastewater treatment plants
• 31 December 2039 for discharges from 60% of those urban wastewater treatment plants, and
• 31 December 2045 for all discharges from those urban wastewater treatment plants

Ireland must establish a list of “sensitive areas” where the concentration or the accumulation of micropollutants from urban wastewater treatment plants pose a risk for the environment or human health. The deadline for this list is 31 December 2030. The designated areas include specific locations where activities are carried out, such as catchment areas for abstraction points, and other areas identified by a risk assessment. The targets to be achieved for populations of 10,000 equivalent in these sensitive areas are as follows:

• 31 December 2033 for 10% of those populations
• 31 December 2036 for 30% of those populations
• 31 December 2039 for 60% of those populations, and
• 31 December 2045 for 100% of those populations

Extended Producer Responsibility Scheme

Quaternary treatment of wastewater will incur significant costs. They will include costs of ongoing monitoring of wastewater and the cost of upgrading WWTPs with new equipment. The EU considers an EPR Scheme to be the most appropriate means to recover these costs under the ‘polluter pays’ principle.

The EU has applied EPR Schemes for other product sectors, such as batteries. These Schemes can limit the impact on the taxpayer, while providing an incentive to producers to develop greener products.

The EPR Scheme will apply to producers who place on the Irish market certain medicinal products for human use[2] and certain cosmetics products[3] (Producers). “Producers” includes:

• Manufacturer
• Importer
• Distributors, and
• Distance sellers

"Placing on the market” means the first making available on the market of a Member State.

The EPR Schemes must ensure that producers cover:

• At least 80% of the full costs of the Member State complying with the quaternary treatment requirements, including the investment and operational costs
• The costs of gathering and verifying data on products placed on the market, and
• Other costs required to exercise their EPR.

Ireland will be obliged to provide an exemption from the EPR Scheme to certain producers. They include producers who can demonstrate, for the products they place on the EU market, that:

• The quantity of the substances contained in the products is below one tonne per year, and
• The substances contained in the products are rapidly biodegradable in wastewater or do not generate micropollutants in wastewater at the end of their life.

Ireland must ensure that an EPR Scheme operator is established and applicable Producers:

• Provide the operator with certain data concerning their products and the substances in the products they place on the market on an annual basis
• Contribute financially to the operator in order to cover the costs arising from their EPR. This is determined on the basis of the quantities and hazardousness in the urban wastewater of the substances contained in the products that are placed on the market, and
• Established on the territory of another Member State or in a third country appoint an authorised representative for the purposes of complying with the EPR requirements.

EPR Scheme operators will be required to publish certain information publicly online, including the financial contributions paid by producers. However, the Revised Directive does provide that the confidentiality of business information must be preserved in accordance with relevant EU and national law.

Impact on industry

As EU Directives do not have direct effect, Member States have a certain level of discretion in how to transpose them into national law. For example, the penalties for non-compliance will be set out in national law, taking into account the criteria in the Revised Directive.

Regarding the requirement that industry should pay for quaternary treatment of wastewater, the Recitals to the Revised Directive specify certain considerations. Member States should assess the possible impacts of the EPR Scheme on the accessibility, availability and affordability of products at national level. This applies in particular to medicines for human consumption. Member States should also consider possible impacts on the “level playing field”.

Article 10(5) of the Revised Directive provides that Member States must organise regular dialogue to ensure its EPR Scheme is implemented as optimally as possible from a cost-benefit perspective. The dialogue should include relevant stakeholders, including producers and distributors, amongst others. It should try to identify measures to:

• Reduce micropollutant pressure at source, and
• Determine the most appropriate technologies for quaternary treatment.

The EPR Scheme must apply to at least 80% of the full costs of the requirements. However, each producer’s contribution is determined on the basis of the quantities and hazardousness in the urban wastewater of the substances contained in the products that are placed on the market. Therefore, producers may want to consider assessing their current “contribution” and whether this can be reduced.

Proposed ban on PFAS

Separate to the Revised Directive, the European Chemicals Agency (ECHA) is considering a proposal to ban PFAS on the EU market. The ban has been proposed jointly by Germany, Denmark, the Netherlands, Sweden, and Norway. The ECHA is currently considering submissions on the proposed ban. It is expected to make a recommendation to the European Commission in 2025 on whether a ban or limited restrictions or derogations should be introduced. An alternative option could, for example, involve conditions allowing the continued manufacture, placing on the market, or use of PFAS instead of a ban. This consideration is particularly relevant for uses and sectors where evidence suggests that a ban could lead to disproportionate socio-economic impacts. Member States will ultimately have to vote on any proposals.

Conclusion

Ireland must ensure the EPR Scheme for producers of medicinal products for human use and cosmetics products is in place by 31 December 2028. Ireland will have until 31 July 2027 to transpose the provisions of the Revised Directive into national legislation.

In the meantime, there should be opportunity for producers and distributors of these products to discuss the implementation of the EPR Scheme with Government. The European Commission may also publish guidance on how the Directive should be transposed by Member States. Producers should avail of any opportunities or guidance to try to ensure the costs they are required to pay do not have the effect of endangering the affordability, availability, or accessibility of these products on the EU market.

In addition, producers should assess their products in terms of their “hazardousness” and potential to give rise to the micropollutants covered by the Revised Directive. This may identify areas where such substances could be changed for alternatives that do not give rise to the applicable micropollutants.

For more information, please contact a member of our Planning & Environment team.

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The content of this article is provided for information purposes only and does not constitute legal or other advice.

[1] Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment.

[2] within the scope of Directive 2001/83/EC

[3] within the scope of Regulation (EC) No 1223/2009