ESRS E2 Pollution [E2] Pollution

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

Impacts, risks, and opportunities

Within the scope of the materiality analysis, Fresenius has identified material impacts related to Pollution:

Approach [E2-1] Policies related to pollution

Environmental Policy

The Environmental Policy substantiates the ambitions regarding pollution, i.e. to prevent or reduce negative environmental impacts such as pollution of air, water, and soil. In the policy, Fresenius commits to complying with the respective legal guidelines and threshold limits at the sites. In addition, it defines the procedures to avoid environmental incidents by established preventative processes. Should such situations nevertheless occur, the company takes measures to limit the negative impact on people and the environment as much as possible.

Further information on the Environmental Policy can be found in the topical standard E1 Climate change, section E1-2 Approach. Information on responsibilities and requirements for the Management Board as well as the Supervisory Board are explained in standard ESRS 2 General disclosures, section GOV-1 Sustainability organization.

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 Operating Companies – e.g., specific regulations on how employees should handle hazardous substances. Management manuals and standard operating procedures provide the framework for local environmental management systems. These can include detailed requirements for evaluating environmental protection measures and processes for assessing environmental risks.

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

Antimicrobial Resistance Industry Alliance

During the production of antibiotics, residues can enter the wastewater. To reduce the negative impacts from its own operations, 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 Operating Company is working on the introduction of AMR Industry Alliance’s Common Antibiotic Manufacturing Framework (CAMF). In 2022, AMR Industry Alliance, with the 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 the 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 stipulates 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 AMR Industry Alliance. PNEC represents the concentration level of a substance in the environment below which no adverse effects are expected.

In 2025, Fresenius Kabi obtained AMR certificates for four antibiotics across three European production sites. The certification process 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 the activities and services of Fresenius, the production sites and the clinics must identify and assess 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:

• Toxic emissions into air, water, or soil

• Consumption of natural resources and raw materials

• Waste and wastewater, packaging

• Transport, or other local environmental impacts

During global internal audits, Fresenius verifies that a proper waste management is in place and processes to avoid toxic emissions are defined. External audits also address these aspects. This enables the company to identify further improvement opportunities 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. Environmental incidents are recorded internally and categorized into five levels depending on their impact. 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 also analyzed 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.

In the reporting year, local environmental incidents were documented in the internal reporting system. Where necessary, Fresenius 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. Fresenius has 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 Fresenius’ current 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 the Group. This may be relevant if, e.g., the quality of a primary product could be impaired as a result.

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

In the reporting year, Fresenius did not adopt any central guidelines for measures relating to the prevention of potential environmental pollution. The environmental management systems provide the framework for activities at the level of the Operating Companies. The focus is on addressing identified risks and complying with applicable guidelines and threshold limits. Further information can be found in the following section Goals and ambitions.

Goals and ambitions [E2-3] Targets related to pollution

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

The goal of Fresenius and the Operating Companies is therefore to comply with the respective legal guidelines and threshold limits at the sites. For this purpose, adequate controls were implemented, e.g., via an environmental management system (see topical standard E1 Climate change, section E1-2 Approach).

Fresenius monitors the effectiveness of the policies by measuring and evaluating defined KPIs. If pollutant concentrations exceed the defined limits, the Group initiates countermeasures. For information about the reporting systems for environmental incidents, please refer in this topical standard to section E2-1 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

At the production sites, Fresenius records 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 nationally defined procedures. When direct measurement is not available due to delayed annual measurement cycles, emissions are estimated. These estimates are based on the previous year’s data. Uncertainties may arise from changes in environmental factors or variations in production volumes. Environmental incidents relevant for reporting are included in pollutant emissions. Since estimates are based on the previous year’s data and any environmental incidents are reported, the level of uncertainty is considered low. Once the data is received, first at Operating Company, second at Group level, the provided input data is validated for 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.

At one site, the E-PRTR threshold value of total organic carbon (TOC) is exceeded due to production-related reasons. Therefore, the following process has been established: The water is treated at the local wastewater treatment plant, with the company covering the costs. Upon subsequent discharge into the public sewer system, the value remains within the permissible range. Two additional sites also exceed the E‑PRTR threshold for TOC. However, the recorded amounts comply with the local wastewater discharge requirements. The sites are assessing options to align future amounts with the E‑PRTR threshold.

The increase of TOC compared to the previous year is due to changes in production volumes.

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.