European Union – Directive on Urban Wastewater Treatment

Date of Adoption: 27 Nov 2024

The Directive was signed on November 27, 2024. Member States must bring into force the laws, regulations and administrative provisions necessary to comply with the Directive by July 31, 2027. Member States have the option to adopt more stringent requirements or accelerate deadlines.

Date of Enforcement: 12 Dec 2024

The Directive aims to protect the environment and public health from urban wastewater discharges. It recasts and updates the previous directive 91/271/EEC to address new and persistent pollution sources.
Member States are the main audience and are required to transpose the Directive into their national law by July 31, 2027, to ensure large urban wastewater treatment plants are upgraded with Quaternary Treatment, and implement the Extended Producer Responsibility (EPR) systems.
Impact on pharmaceutical companies: Once Member States transpose the Directive into national law, pharmaceutical companies will have a direct national-level legal obligation to:  
  • Join a designated Producer Responsibility Organisation (PRO).
  • Pay a financial contribution to the PRO, calculated based on the quantity and hazardousness of the products they place on the EU market.  

The PSCI is not a certification or compliance body but it offers tools to members that can used as part of your company’s due diligence processes.

Please note that this summary was drafted by the PSCI Secretariat. PSCI members and suppliers are advised to read the legislation in its entirety.

Link to the Directive: here

Extended Producer Responsibility

Legislative provisions

The following legislative provisions are included:

  1. Producers who place any of the products listed in Annex III (i.e. medicinal products for human use that fall under Directive 2001/83/EC, and Cosmetic products that fall under Regulation (EC) No 1223/2009) on the market have extended producer responsibility. Those producers will be required to cover:

    1. at least 80 % of the full costs for complying with the requirements set out in Article 8 (Quaternary treatment*), including the investment and operational costs for the quaternary treatment of urban wastewater to remove micropollutants resulting from the products they place on the market and from the residues of those products, and for the monitoring of micropollutants;
    2. the costs for gathering and verifying data on products placed on the market; and
    3. other costs required to exercise their extended producer responsibility.

  2. Producers will be exempt from their extended producer responsibility under paragraph 1 where they can demonstrate any of the following:

    1. the quantity of the substances contained in the products they place on the Union market is below 1 tonne per year;
    2. the substances contained in the products they place on the market are rapidly biodegradable in wastewater or do not generate micropollutants in wastewater at the end of their life.
  3. Producers shall exercise their extended producer responsibility collectively through an organisation that fulfils the minimum requirements set out in Article 10.
    1. Those producers are required to provide the producer responsibility organisations once a year with the following: the annual quantities of the substances contained in medicinal products for human use (falling under Directive 2001/83/EC), and cosmetic products (falling under Regulation (EC) No 1223/2009 that they place on the market in the context of their professional activity; information on the hazardousness of the substances contained in products referred to in the point above in the urban wastewater and on their biodegradability at the end of their life; when relevant, a list of products exempted in accordance with paragraph 2.
    2. Those producers are required to contribute financially to the producer responsibility organisations in order to cover the costs arising from their extended producer responsibility.
    3. Each producer’s contribution, as referred to in the point above, 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.
    4. Producer responsibility organisations are subject to annual independent audits of their financial management, including their capacity to cover the costs referred to in paragraph 1, the quality and adequacy of the information collected and the adequacy of the contributions collected.
    5. The measures necessary to inform consumers about waste prevention measures, take-back and collection systems, and the impact of inappropriate means of waste disposal of the relevant pharma and cosmetics products, as well as their mis- and over-use, on the collection, treatment and discharge of urban wastewater are taken.

  • Directive, Article 9

    *Definition of 'Quaternary treatment': Treatment of urban wastewater by a process which reduces a broad spectrum of micropollutants in urban wastewater.

     

PSCI Principles

The following PSCI Sub-Principles are relevant to this issue:
Environment Environmental authorizations & reporting
Suppliers shall comply with all applicable environmental regulations. All required environmental permits, licenses, information registrations and restrictions shall be obtained, and their operational and reporting requirements followed.
Environment Waste & emissions
Suppliers shall have systems in place to ensure the safe handling, movement, storage, disposal, recycling, reuse, or management of waste, air emissions and wastewater discharges. Any waste, wastewater or emissions with the potential to adversely impact human or environmental health shall be appropriately managed, controlled and treated prior to release into the environment. This includes managing releases of active pharmaceuticals into the environment (PiE).
Governance & Management Systems Legal & customer requirements
Suppliers shall identify and comply with applicable laws, regulations, recognized standards, and relevant customer requirements.
Human Rights Local communities
Suppliers shall respect the rights of the local communities around their sites including the right to a clean and healthy environment.

Resources

You may find the following PSCI Resources useful as part of your company’s due diligence process on this issue:

Companies in Scope

The scope of this Directive primarily targets EU Member States and the Producer Responsibility Organisations (PROs). However, pharma companies also fall in scope with requirements related to Extended Producer Responsibility (EPR) schemes to fund the removal of micropollutants. The core purpose of this EPR is to apply the "polluter pays" principle to the pharmaceutical and cosmetics sectors, who together are expected to cover at least 80% of the costs of quaternary treatment* on the basis that residues from those two industries currently represent the main sources of micropollutants found in urban wastewater requiring quaternary treatment.

Products covered by the EPR are:

  • Medicinal products for human use falling within the scope of Directive 2001/83/EC.
  • Cosmetic products falling within the scope of Regulation (EC) No 1223/2009.

The EPR requirements apply to "producers", regardless of whether the products are placed on the market, or whether their individual components were manufactured in a Member State or third country, or whether the producers have a registered office in the Union or the product is placed on the market via a digital platform.

*Quaternary treatment: Treatment of urban wastewater by a process which reduces a broad spectrum of micropollutants in urban wastewater.

Business Requirements

Key business requirements include:

  • Extended Producer Responsibility: Producers are required to take financial responsibility for the additional costs of quaternary treatment necessary to remove micropollutants from wastewater i.e. make a financial contribution ...
  • ... Financial Contributions: These contributions must be proportionate to the quantities and hazardousness of the substances in the products placed on the market. They are intended to cover the investment and operational costs of monitoring and treatment.
  • Producer Responsibility Organisation: Producers are expected to exercise their EPR obligations through a centralized organization (PRO).
Penalties/ Non-compliance/ Enforcement & Sanctions

Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.

Penalties should give due regard to the following, as applicable:

  • the nature, gravity, and extent of the infringement;
  • where appropriate, the intentional or negligent character of the infringement;
  • the population or the environment affected by the infringement, bearing in mind the impact of the infringement on the objective of achieving a high level of protection of the environment and human health;
  • the repetitive or singular character of the infringement;
  • the financial situation of the natural or legal person held responsible.
Key Definitions

For the purposes of this Directive, the following definitions apply:

  • Urban wastewater means any of the following:
    (a) domestic wastewater;
    (b) the mixture of domestic wastewater and non-domestic wastewater;
    (c) the mixture of domestic wastewater and urban runoff;
    (d) the mixture of domestic wastewater, non-domestic wastewater and urban runoff;

  • Domestic wastewater means wastewater from residential settlements, services and institutions which originates predominantly from the human metabolism or from household activities, or from both;

  • Non-domestic wastewater means wastewater, other than domestic wastewater and urban runoff, which is discharged from premises used for the exercise of a trade or industrial or economic activities;

  • Agglomeration means an area where the population expressed in population equivalent, combined or not with economic activities, is sufficiently concentrated for urban wastewater to be collected and conducted to one or more urban wastewater treatment plants or to one or more final discharge points;

  • Urban runoff means precipitation in agglomerations collected by combined or separate sewers;

  • Storm water overflow means discharge of untreated urban wastewater into receiving waters from combined sewers caused by precipitation or system failures;

  • Collecting system means a system of conduits which collects and conducts urban wastewater;

  • Combined sewer means a single conduit that collects and conducts urban wastewater, including urban runoff;

  • Separate sewer means a conduit that separately collects and conducts one of the following:
    (a) domestic wastewater;
    (b) non-domestic wastewater;
    (c) a mixture of domestic and non-domestic wastewater;
    (d) urban runoff;

  • 1 population equivalent or ‘(1 p.e.)’ means the organic biodegradable load per day, having a five-day biochemical oxygen demand (BOD5) of 60 g of oxygen per day;

  • Primary treatment means treatment of urban wastewater by a physical or chemical process, or both, involving settlement of suspended solids, or other processes in which the BOD5 of the incoming wastewater is reduced by at least 20 % before discharge and the total suspended solids of the incoming wastewater are reduced by at least 50 %;

  • Secondary treatment means treatment of urban wastewater by a process generally involving biological treatment with a secondary settlement or another process which reduces biodegradable organic matter from urban wastewater;

  • Tertiary treatment means treatment of urban wastewater by a process which reduces nitrogen or phosphorus, or both, in urban wastewater;

  • Quaternary treatment means treatment of urban wastewater by a process which reduces a broad spectrum of micropollutants in urban wastewater;

  • Sludge means organic and inorganic residue resulting from the treatment of urban wastewater from an urban wastewater treatment plant, excluding grit, grease, other debris and any other screenings and residues from the pre-treatment step;

  • Eutrophication means the enrichment of water by nutrients, especially compounds of nitrogen or phosphorus, or both, causing an accelerated growth of algae and higher forms of plant life to produce an undesirable disturbance to the balance of organisms present in the water and to the quality of the water concerned;

  • Micropollutant means a substance as defined in Article 3(1) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (32), including its breakdown products, that is usually present in the aquatic environment, urban wastewater or sludge and that can be considered hazardous to the environment or human health on the basis of the relevant criteria set out in Parts 3 and 4 of Annex I to Regulation (EC) No 1272/2008, even in low concentrations;

  • Dilution ratio means the ratio of the average over the last five years of annual flow of the receiving waters at the point of discharge to the average over the last five years of the annual discharge volume of urban wastewater into surface waters;

  • Producer means any manufacturer, importer or distributor that on a professional basis places products on the market of a Member State, including by means of distance contracts as defined in Article 2(7) of Directive 2011/83/EU of the European Parliament and of the Council;

  • Producer responsibility organisation means a nationally recognised organisation established to enable producers to fulfil their obligations under Articles 9 and 10;

  • Sanitation means facilities and services for the safe, hygienic, secure, and socially and culturally acceptable management and disposal of human urine and faeces, and for the changing and disposal of menstrual products, that provide privacy and ensure dignity;

  • Antimicrobial resistance means the ability of micro-organisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill micro-organisms of the same species;

  • One Health means One Health as defined in Article 3, point (7), of Regulation (EU) 2022/2371 of the European Parliament and of the Council;

  • Public concerned means the public affected or likely to be affected by, or having an interest in, the taking of a decision for the implementation of the obligations laid down in Article 6, 7 or 8 of this Directive; for the purposes of this definition, non-governmental organisations promoting the protection of the environment or human health and meeting any requirements under national law are deemed to have an interest;

  • Biomedia means any support, usually made of plastic, used for the development of the bacteria needed for the treatment of urban wastewater;

  • Placing on the market means the first making available of a product on the market of a Member State;

  • Load means the amount of organic biodegradable matter measured as BOD5 in urban wastewater, expressed in p.e., or of any pollutant or nutrient, expressed in mass units per time;

  • Individual system means a sanitation facility that collects, stores, treats or disposes of domestic wastewater from buildings or parts of buildings not connected to a collecting system.