Advocate General’s Opinion Raises Evidential Bar for EU Environmental Legislation Affecting Pharma and Cosmetics

Summary

Advocate General Kokott’s Opinion in Case C‑193/25 proposed that the EU Court of Justice annul key parts of Directive (EU) 2024/3019, which would have required pharmaceutical and cosmetics producers to pay at least 80% of advanced wastewater treatment costs. Her analysis exposes weak scientific and evidential foundations for this extended producer responsibility (EPR) regime.

An Advocate General’s opinion at the Court of Justice of the European Union is not legally binding. However, it carries significant persuasive authority and often has a substantial influence on the Court’s final rulings.

If the Court of Justice follows her Opinion, the immediate financial burden on these sectors will be lifted, national implementation will be disrupted and future environmental laws will face stricter evidential scrutiny. Importantly, the Opinion does not rule out EPR altogether; it signals that the EU legislature may consider a revised version of the law, provided it is grounded in robust scientific evidence and a defensible methodology for cost allocation.

************************

On 3 September 2026, Advocate General Kokott delivered a decisive Opinion in Republic of Poland v European Parliament and Council (Case C‑193/25). She targeted Article 9(1)(a) and Annex III of Directive (EU) 2024/3019, which required pharmaceutical and cosmetics producers to cover most costs for quaternary wastewater treatment—a form of extended producer responsibility (EPR) making industries pay for pollution caused by their products.

An Advocate General’s opinion at the Court of Justice of the European Union is not legally binding. However, it carries significant persuasive authority and is often influential on the Court’s final rulings.

Advocate General Kokott’s analysis raises the bar for EU environmental legislation. She stressed that lawmakers must show, “clearly and unambiguously”, that they exercised their discretion based on solid facts. The scientific basis for the 80% cost allocation was found lacking, relying on questionable toxic-load figures (PNEC-weighted) and heavily influenced by a few pharmaceutical substances. The Advocate General argued that alternative scientific values could drastically change the cost split, undermining the Directive’s justification.

She also tied the polluter-pays principle to equal treatment, insisting that only producers with a proven causal link to pollution should bear costs. If the Court adopts this logic, future EPR schemes must be backed by robust evidence and a clear causal connection.

Should the Court follow the Advocate General’s Opinion, Member States will face immediate disruption. National EPR schemes due by December 2028 would lose their legal basis, halting or reversing legislative efforts. Ongoing legal challenges, including an Irish preliminary reference, could amplify uncertainty across the EU. Member States that have already begun drafting or enacting implementing legislation will be left in limbo, unsure whether to proceed, pause, or withdraw their measures.

The Advocate General’s Opinion is procedural, not a rejection of EPR itself. She leaves room for revised legislation—provided it is built on stronger science and fairer cost attribution. Any new regime must address the inclusion of other pollutant sources, proportionate cost splits, and the limited ability of generic drug makers to change product formulas. The Advocate General’s reasoning suggests that the legislature could revisit the issue, but only if it can demonstrate a robust scientific assessment and a defensible methodology for attributing micropollutant loads to specific sectors.

For the pharmaceutical and cosmetics industries, the impact is direct and substantial. If Article 9(1)(a) is annulled, the immediate financial liability disappears. The Advocate General highlighted that EPR offers little incentive for generic drug makers, who are bound by regulatory requirements and cannot reformulate to avoid pollutants. This means the regime would function as a pure levy rather than an innovation incentive for much of the pharmaceutical market—a fundamental design flaw that any successor regime must address. For cosmetics, she questioned whether certain substances genuinely originate from cosmetic use, casting doubt on the evidence for imposing EPR costs. The findings on cosmetics’ toxic load were considered manifestly inadequate, further undermining the rationale for subjecting cosmetics producers to the same obligations as pharmaceutical producers.

The Opinion has already created commercial uncertainty. Companies that factored EPR costs into pricing, procurement, and supply chains may need to rethink their strategies. Both sectors are now better positioned to influence any successor regime, armed with the Advocate General’s insistence on scientific rigour and demonstrable causality. Industry stakeholders will have concrete grounds to engage with the Commission during any future impact assessment or legislative consultation.

In short, the Advocate General’s Opinion puts the EU’s EPR cost burden for pharmaceuticals and cosmetics in jeopardy. If adopted, it will remove immediate obligations, disrupt national plans, and set a new standard for evidence in environmental cost allocation. The pharmaceutical and cosmetics sectors will benefit from reduced financial exposure but will need to remain vigilant as the EU legislature considers a possible successor regime.

Subscribe to Ropes & Gray Viewpoints by topic here.