Wastewater Directive 2028 – producer responsibility for medicines and cosmetics
EU wastewater producer responsibility for medicines and cosmetics: 80% costs, one-tonne substance exemption, Swedish implementation and pending EU Court case.
The revised Urban Wastewater Treatment Directive (EU) 2024/3019 sets out a forthcoming extended producer responsibility system for certain medicinal products for human use and cosmetics. Under Article 9, Member States must establish arrangements by 31 December 2028 under which producers finance a significant share of quaternary treatment of micropollutants. Sweden has not finalised the fee and administration model, and part of the funding rule is contested before the EU Court of Justice. Separate adopted EU provisions, domestic implementation and pending litigation.
Which medicines and cosmetics are covered?
Article 9 refers to the Annex III categories, including human medicines under EU medicines law and cosmetic products under the Cosmetics Regulation. Selling through a pharmacy or beauty store alone does not establish scope. Check each product’s legal classification and the applicable Annex III wording.
Identify the producer as defined in the Directive, considering the manufacturer, importer, distributor and relevant distance-sales situations, the legal entity and the Member State where products are placed on the market. Do not assume that every retailer or end user is liable. Sweden’s future implementation may further specify registration and reporting procedures.
What is decided and what remains uncertain?
| Issue | EU provision | Status at 11 November 2026 |
|---|---|---|
| Entry into force | Directive (EU) 2024/3019 entered into force on 1 January 2025. | Adopted EU law. |
| Swedish transposition | The main provisions must be transposed by 31 July 2027. | National implementation is in progress; practical arrangements are not final. |
| EPR system | Article 9 envisages an EPR system for Annex III products by 31 December 2028. | Directive remains in force; financing provision is disputed in court. |
| Funding | Article 9(1)(a): at least 80% of specified quaternary treatment and monitoring costs. Additional data and EPR costs are separate. | Not a fixed invoice for an individual company or 80% of sales. |
| Exemptions | Article 9(2) has a threshold below one tonne of substances per year and a separate environmental-substance exemption. | Evidence required; detailed implementing criteria still relevant. |
| EU case C-193/25 | The Advocate General proposed on 3 September 2026 that Article 9(1)(a) and Annex III be annulled. | A non-binding opinion, NOT a judgment; case pending. |
What does 80% actually mean?
The at-least-80% rule concerns costs defined in Article 9(1)(a), related to quaternary wastewater treatment and micropollutant monitoring. Points (b) and (c) also address costs of data collection, verification and other EPR obligations. They do not predetermine any company's Swedish annual fee or a percentage of turnover. The national system, cost allocation and administration need to be established according to the applicable legal framework.
Under Article 9(3), producers exercise responsibility collectively through a producer responsibility organisation. Annual information may include quantities placed on the market and relevant substances’ environmental characteristics. Prepare reliable data, but mark any fee estimate as provisional rather than a government rate.
Does the one-tonne exemption refer to products or substances?
Article 9(2)(a) refers to the amount of SUBSTANCES contained in products that one producer places on the Union market being below one tonne per year. Do not equate this with total packaged product weight, revenue or an automatic separate tonne threshold for each SKU. Document relevant substance, product range, year, volumes and legal entity. Calculation methods and domestic evidence requirements may be clarified later.
Article 9(2)(b) provides another possible exemption for rapidly biodegradable substances or products that do not generate micropollutants in wastewater at end of life. It requires credible scientific support, not merely a 'natural' or 'green' claim. Under Article 9(5), more detailed criteria are due from the Commission by 31 December 2027; verify whether they have been adopted at the time of assessment.
Evidence matrix for company preparations
| Control area | Keep this evidence | Avoid this error |
|---|---|---|
| Product scope | SKU, regulatory category, revision and Annex III category. | Grouping all pharmacy or skincare goods automatically. |
| Producer role | Legal entity, Member State, import/market role and supply chain. | Assigning liability to all retailers without analysis. |
| Annual substance quantities | Substance identifiers, verified concentration, applicable sales volume and calculation. | Using total product weight against the tonne threshold. |
| Environmental properties | Studies, methods, degradability, hazard data and supplier documents. | Claiming exemption based on marketing language. |
| Legal status and decision | Date of law check, reviewer, pending national measures and Court outcome. | Treating a proposal or Advocate General opinion as binding law. |
This is a practical evidence matrix, not an official filing form or an exemption certificate. Keep versions and references so any later report can be examined.
Three practical situations
Company with several human medicines
A company marketing different human medicines maps each regulated product, substance quantity and market. It records verified ingredients and annual volumes. Total package weight alone cannot establish the under-one-tonne condition.
Cosmetic brand using a contract manufacturer
A Swedish cosmetics brand outsources manufacturing but sells across markets. It evaluates who is the defined producer, requests real formulation data and maps country-by-country sales. A manufacturing contract does not automatically settle public-law responsibility.
Company reacts to the Advocate General opinion
Management reads a proposal to annul the financing rule and plans to stop gathering evidence. This is premature: an opinion does not decide the case. Continue proportionate preparation, monitor the judgment and avoid irreversible decisions based on speculation.
Seven steps for preparation
- Inventory the potentially covered human medicines and cosmetics, SKUs and countries.
- Identify the legally responsible producer and entity for each relevant market.
- Request substantiated substance identity, formulation version, concentration and supplier evidence.
- Calculate annual substance quantities transparently, separating verified figures from assumptions.
- Assess possible exemptions with documented calculations or scientific evidence; do not self-issue regulatory approval.
- Monitor Naturvårdsverket, Swedish implementation and Commission acts. TLV and the Medical Products Agency are due to submit an interim report by 16 November 2026.
- Monitor case C-193/25 and revise the legal assessment only when a binding judgment or legal amendment occurs.
Frequently asked questions
Is this already a Swedish producer fee in 2026?
No. The directive is adopted, but Swedish procedures and fee levels are not final. Article 9 refers to 31 December 2028 unless the legal position changes.
Is the tonne threshold for products or substances?
Article 9(2)(a) refers to the amount of substances in covered products placed on the Union market by a producer per year, not automatic total product weight or a separate per-SKU limit.
Has the Court annulled the producer responsibility scheme?
No, not on 11 November 2026. The Advocate General proposed annulment of Article 9(1)(a) and Annex III on 3 September. The non-binding opinion is not the Court's judgment.
Can an online cosmetics seller be covered?
Possibly. It depends on the product category and producer definition, not just whether the sale is online. Relevant national rules must also be considered.
Is a Word or Excel checklist sufficient for exemption?
No. It can organise genuine evidence but cannot replace statutory proof, competent review or technical verification.
Document templates for medicines and cosmetics
Choose the template pack that fits the regulated product category:
- Medicines & Wastewater Directive 2028 – substance masses, 1-ton test and PRO basis | Word/PDF/Excel
- Cosmetics & Waste Water Directive 2028 – Extended Producer Responsibility, 1-Ton Test & Substance Register | Word/PDF/Excel
The templates are optional; the guide explains the rules and exemptions independently of any purchase.
Official sources and review date
- Directive (EU) 2024/3019: Articles 2, 9–10 and Annex III
- Naturvårdsverket – Swedish implementation
- Swedish government – TLV and Medical Products Agency task
- Advocate General opinion C-193/25, 3 September 2026
- Court of Justice – pending case C-193/25
Editorial source review: 11 November 2026. This describes adopted EU law, Swedish implementation work and pending litigation; it is not individual legal advice, laboratory testing or regulatory approval. Recheck official sources before relying on any decision.
