ESRS E2 Pollution [E2] Pollution

Our impacts, risks, and opportunities [E2 SBM-3] Material impacts, risks, and opportunities and their interaction with strategy and business model

As a healthcare Group, Fresenius feels a responsibility to protect the environment and use natural resources carefully, because only a healthy environment can be a home for healthy people. Despite our efforts, we cannot prevent all negative effects from production given the size of our Group and our business model. For our hospital business, pollution is not a material topic.

The pharmaceutical manufacturing process at our production sites can result in the losses of pollutants to air and water. If the thresholds are exceeded, pollutants can have a potential negative impact on the environment. Reduced air or water quality can negatively affect human health.

Both the production and use of intravenous antibiotics are associated with residues in wastewater. Therefore, we detect antibiotic residues in the wastewater from our operational business, due to our production and the application of antibiotics in our healthcare facilities. Furthermore, downstream, residues from the administration of medication in other healthcare facilities also enter the wastewater and can also have a negative impact on local water quality.

Our approach [E2-1] Policies related to pollution

Environmental Policy

At Group level, we have an Environmental Policy, which also addresses the issue of pollution. It substantiates our ambition to prevent or reduce negative environmental impacts such as pollution of air, water and soil. In the guideline, we commit to complying with the respective legal guidelines and threshold limits at our sites. In addition, it defines our procedures to avoid environmental incidents by established preventative processes. Should such situations nevertheless occur, we take measures to limit the negative impact on people and the environment.

Further information on the Environmental Policy can be found in the topical standard E1 Climate change, section E1-2 Our approach.

Further policies related to pollution

All locations are subject to the respective local regulations and laws. In addition, internal guidelines on environmental protection are implemented at the business segments – e.g., specific regulations on how employees should handle hazardous substances. Management manuals and standard operating procedures provide the framework for the local environmental management system. These can include detailed checklists for evaluating environmental protection measures and forms for assessing environmental risks.

Further information on our comprehensive environmental management and monitoring processes can be found in the topical standard E1 Climate change, section E1-2 Our approach.

Antimicrobial Resistance Industry Alliance (AMRIA)

During the production of antibiotics, residues can enter the wastewater. To reduce the negative impacts that we cause in this regard in our own business, Fresenius Kabi has been a member of the Antimicrobial Resistance (AMR) Industry Alliance since 2020, working to promote responsible antibiotic production. Since 2021 Fresenius Kabi has also been actively involved in the association’s governing bodies. The business segment is working on the introduction of AMRIA’s Common Antibiotic Manufacturing Framework (CAMF).

In 2022, AMRIA, with participation of Fresenius Kabi, and BSI Standards Limited released the Antibiotic Manufacturing Standard, providing guidance to manufacturers on responsible antibiotic production. The goal is to minimize the risk of developing antibiotic resistance and reduce aquatic ecotoxicity in the environment resulting from the manufacturing of human antibiotics. The standard complements the already-high production quality and safety management at our production sites. A pivotal component of the approach involves the use of a risk-based methodology to evaluate and control the waste streams generated during antibiotic manufacturing.

The implementation, which began in 2022, involved the introduction of a comprehensive quantification mass balance template by Fresenius Kabi. The template’s function is to assist antibiotic manufacturing sites in determining antibiotic concentrations in manufacturing wastewater discharge and conducting gap analyses, with the overarching goal of aligning with the Predicted No-Effect Concentrations (PNEC) set forth by AMRIA. PNEC represents the concentration level of a substance in the environment below which no adverse effects are expected. The business segment is currently working on obtaining AMR certificates for some of its antibiotics manufactured in Europe. This involves an independent audit to confirm that antibiotic residues in waste streams are properly controlled during production.

Furthermore, a dedicated communication channel connects local sites with the global EHS team (Environment, Health, and Safety). This initiative fosters continuous alignment with the Antibiotic Manufacturing Standard, ensuring ongoing adherence and improvement in the future.

Identification and management of environmental risks

To minimize the negative environmental impacts associated with our activities and services, our production sites and our clinics in Germany and Spain must identify these impacts and develop environmental protection measures. They must also regularly review these measures for effectiveness.

The following topics can be addressed in this context:

• Emissions into air, water, or soil
• Consumption of natural resources and raw materials
• Waste and wastewater, packaging
• Transport, or other local environmental impacts

Furthermore, using our global internal audits, we identify further improvement opportunities at our sites and develop appropriate measures with locally responsible managers to tap that potential. The frequency of global internal audits depends on audit observations from previous audits, environmental incidents, certification status, or the evaluation of the management review, and can vary between one and four years.

Reporting systems

In the production area, a reporting process is implemented for environmental incidents such as violations of environmental regulations, pollution caused by uncontrolled spills, or complaints from third parties. We record environmental incidents internally and categorize them into five levels – depending on the impact of an environmental incident. Local managers report these incidents to the global EHS function responsible for production as soon as they become aware of them. Where necessary, environmental incidents are immediately reported to the relevant authorities by the EHS function. Environmental incidents are analyzed by the EHS function together with the respective site to determine the cause and to prevent further incidents. Depending on the local regulations, serious incidents are analyzed also by the authorities.

At the hospitals, there are reporting processes for incidents that require immediate communication to the local community, such as the release of hazardous substances or accidents in the areas of energy or water. In addition to rectifying an incident, internal and external communication involving the relevant authorities where necessary takes place immediately, depending on the situation, followed by an investigation into the cause.

In the reporting year, no environmental incidents were reported via the reporting channels whose impact would have been material to the financial position or reputation of the company. Furthermore, no incidents were recorded in which the respective environment or the general public were directly harmed due to default. Further information on opportunities and risks can be found in the Opportunities and Risk Report.

In the reporting year 2024, we documented local environmental incidents in the internal reporting system. Where necessary, we informed responsible authorities of the incidents immediately after an incident became known of. Necessary measures were implemented to reduce the environmental impact of the respective incidents. We have also taken the environmental incidents at the affected sites as an opportunity to implement preventive measures, such as training courses, in order to avoid future incidents. To our knowledge, no incident led to a severe impact on the environment, biodiversity, or the communities nearby.

If contractually agreed, environmental incidents from the upstream and downstream value chain must also be reported to us. This may be relevant if, for example, the quality of a primary product could be impaired as a result.

Our actions [E2-2] Actions and resources related to pollution

In the reporting year 2024, Fresenius did not adopt any central guidelines for measures relating to the prevention of potential environmental pollution. At present, approaches to this are mainly organized locally, but the framework is provided by the environmental management systems of the business segments.

In the course of the operating business we conducted activities at the local level in 2024 that aim to address potential impacts, risks, or opportunities related to pollution. For example, at our production site Vicchio in Italy, a project was initiated that aims at reducing the sulphate concentration in wastewater. Implementation is planned for 2025.

Our goals and ambitions [E2-3] Targets related to pollution

It is our ambition to avoid or minimize any negative impact on the environment that may arise from our direct business operations or from downstream activities. This also includes avoiding unnecessarily polluting the sources from which we obtain water or into which we discharge our wastewater. Pollutants released into air, soil, and water must be limited and unnecessary discharges avoided altogether.

The goal is therefore to comply with the respective legal guidelines and threshold limits at our sites. We have implemented adequate controls for this purpose, e.g. via an environmental management system (see topical standard E1 Climate change, section E1-2 Our approach).

We monitor the effectiveness of our policies by measuring and evaluating defined KPIs. If pollutant concentrations exceed the defined limits, we initiate countermeasures. For information about our reporting systems for environmental incidents, please refer in this topical standard to section E2-1 Our approach, Reporting systems.

Furthermore, there is no overarching Group target in connection with potential environmental pollution.

Metrics

Pollution of air and water – pollutants [E2-4] Pollution of air and water – pollutants

At our production sites, we record the emission of pollutants into air and water in accordance with legal regulations. Depending on the pollutant, measurements are taken at exhaust gas or wastewater points, following internationally recognized measurement standards such as ISO standards or national selected procedure. When direct measurement is not available due to delayed annual measurement cycles, emissions are estimated. These estimates are based on the previous year’s figures considering changes of the site’s production activity. Uncertainties remain due to environmental factors or unforeseen events. Since estimates are based on previous year’s figures, the degree of uncertainty is assumed to be low. Once the data is received, first at business segment second at Group level, the provided input data is validated on completeness and accuracy. Discrepancies are addressed with site representatives and corrected or justified. The emission measurements are carried out and validated in-house or by external certified inspection bodies.

In the reporting year, our emissions of pollutants exceeded the thresholds defined in the E-PRTR regulation (European Pollutant and Transfer Register) in one case. The annual threshold for the pollutant organic carbon (TOC) (as total organic carbon or COD / 3) is 500,000 kg per year per plant. This threshold was exceeded at one plant: the total quantity of the pollutant was 698,284 kg at that plant in 2024. The amount of pollutants is measured at the discharge point of the plant and quantified via annual individual measurements using gas chromatography methods. The wastewater is discharged to an external water treatment plant where it is treated.

For information about air emissions that are to be reported in the topical standard E1 Climate change, please refer to that topical standard, section E1-6 GHG emissions.