Waste water directive 2025 - ROP for micropollutants will burden cosmetics and pharmaceutical companies

On 1 January 2025, the new EU Wastewater Directive (2024/3019) entered into force, which introduces a system of extended producer responsibility (ROP) for micropollutants discharged into wastewater. Member States have until the end of July 2027 to implement the legislation and establish national ROP systems. National systems will become operational by 31 December 2028 at the latest, when most of the costs of the so-called fourth-tier treatment will be covered by cosmetics and medical device manufacturers.

Directive 2024/3019 will take care of water purity

From 1 January 2025, Directive (EU) 2024/3019 of the European Parliament and of the Council on the treatment of urban waste water (the so-called Wastewater Directive) applies, which obliges EU Member States to make numerous changes to the way they manage waste water. This is the first revision of the EU's urban wastewater treatment legislation in 33 years and aims to address current challenges in wastewater management.

One of the key elements of the Wastewater Directive is the introduction of extended producer responsibility (ROP) for micropollutants in wastewater. As intended by the EU legislator, a key element of the ROP will be the obligation to cover the 80% costs associated with the construction and operation of the fourth stage treatment facility by those responsible for introducing the majority of micropollutants into municipal wastewater. This group mainly includes pharmaceutical and cosmetics manufacturers. The remaining 20% of investment and operating costs will be covered in the existing way, i.e. from the budgets of local governments (usually municipalities).

Micropollutants and new challenges for the treatment system

According to the European Commission, pharmaceutical and cosmetic product residues are currently the main source of micropollutants in municipal wastewater. These substances, even at very low concentrations, can damage aquatic ecosystems, disrupt the endocrine balance of organisms and accumulate in food chains.

In order to remove them effectively, so-called fourth-stage cleaning is needed, which includes ozonation, activated carbon adsorption, membrane filtration and advanced oxidation processes (AOPs). However, adapting existing treatment plants to the requirements of this method is very costly - involving significant investment in infrastructure, followed by high operating and maintenance costs. As intended by the EU legislator, The costs of this clean-up phase will be passed on to producers at a minimum of 80%.

Read also:  When is it necessary to submit a notification for the upgrading of an existing wastewater treatment plant? Key information about the notification of an installation that does not require a permit

The amount of producers' mandatory ROP contributions will depend on:

• the quantities of substances present in the wastewater that are identical to those used by the company in question in its products,
• the degree of harmfulness of these substances.

At the same time, pharmaceutical and cosmetics manufacturers will be required to fund at least 80% costs of monitoring micropollutants and collecting and reporting data on products and their residues.

How will the ROP system for micropollutants work?

Extended producer responsibility for wastewater micropollution will include:

• manufacturers of medicinal products for human use covered by Directive 2001/83/EC of the European Parliament and of the Council,
• manufacturers of cosmetic products covered by Regulation (EC) No 1223/2009 of the European Parliament and of the Council.

By producer the Directive means not only the manufacturer of the product, but also its importer, distributor and seller (including distance sellers using their own online shop or sales platform). All of these operators will soon have to partner with producer responsibility organisations to collect and manage the financial contributions made under the ROP. These organisations are to operate on similar principles as in other ROP schemes (e.g. for packaging or electro-waste) and transfer the funds to the treatment plant operators.

The following may be exempted from the ROP obligations exempted operators who place on the market less than 1 tonne of substances per year or prove that their products are biodegradable and do not generate micropollutants. By the end of 2027, the European Commission will develop common criteria for assessing biodegradability and environmental risks, which will form the basis for these exceptions.

The new role of the producer responsibility organisation (PLO)

Producer responsibility organisations will become the financial and operational pillar of the new system. They will:

• collect data on products, their quantities and composition,
• charge ROP according to the type of substance used,
• transfer funds for the modernisation and operation of the treatment plant,
• conduct financial audits and report results,
• carry out education and information activities.

Member States, including Poland, will have to establish national procedures for the recognition and supervision of producer responsibility organisations, which requires the implementation of new national legislation implementing the provisions of the directive.

Challenges for the pharmaceutical and cosmetics industry

For pharmaceutical and cosmetics manufacturers, the new regulations mean not only financial obligations, but also the need to adapt production, reporting and testing processes.

Companies will have to:

• analyse the composition of their products for substances that fall under the scope of sewage micropollutants,
• develop a system for reporting data on substances and their biodegradability,
• modify the financial models to include ROP costs,
• invest in research into biodegradable and less harmful product ingredients,
• develop a „green by design” strategy, minimising the environmental footprint of products.

It is worth emphasising at this point that the adaptation of activities to the requirements of the Wastewater Directive is not the only challenge for this group of entrepreneurs, especially for cosmetics manufacturers. In parallel, they must ensure that their packaging complies with the requirements of the PPWR and eco-modulation, and adapt to the extended producer responsibility systems for packaging operating in individual Community countries.

Read also: Cosmetics industry facing PPWR - mandatory eco-design of cosmetics packaging

Timetable for implementation of the Wastewater Directive (EU) 2024/3019

• 1 January 2025 - entry into force of the Directive,
• 31 July 2027 - deadline for transposition of the Directive into national law,
• 31 December 2027 - Adoption of implementing acts establishing EU biodegradability and hazard criteria,
• 31 December 2028. - start of operation of national ROP systems,
• 2033-2045 r. - Successive implementation of fourth stage treatment.

Sources:

1. Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban waste water treatment, https://eur-lex.europa.eu/legal-content/PL/TXT/PDF/?uri=OJ:L_202403019