EU Establishes Positive Substances Lists for Drinking Water

By Brigitta Liber, Senior Regulatory Specialist, Supply Chain team, UL Solutions

In Dec. 2020 the European Drinking Water Directive (DWD) was re-cast with updated water quality standards concerning emerging pollutants such as endocrine disruptors and microplastics. The recast was a direct response to the “Right2Water” citizen initiative. Member States were required to transpose the Directive into national law by Jan. 2023. With the transposed legislative measures, EU citizens can be assured to have one of the highest drinking water standards in the world. The standards ensure cleaner water from the tap, promote sustainable water management and protect public health.

The DWD requires that substances, compositions, and constituents used in materials that come into contact with drinking water be registered in one of the four positive lists, ensuring that water remains safe from the water source to the tap. These lists aim to establish a harmonized framework across the EU, enabling the free flow of goods while ensuring that all materials in contact with drinking water adhere to the same rigorous safety and quality standards.

On April 23, 2024, the EU Commission published six legal acts, three implementing decisions (EU 2024/ 365, EU 2024/367, EU 2024/368) and three delegated regulations (EU 2024/369, EU 2024/370, EU 2024/371) to supplement the Drinking Water Directive.

Commission Implementing Decision 2024/367 establishes the first European positive lists of materials or products that come into contact with water intended for human consumption.

These lists are based on the national positive lists that EU member states notified to European Chemicals Agency (ECHA) in 2021. It includes four different types of material categories:

• Annex I includes Organic Materials, such as plastic food contact materials. This list incorporates Annex I of EU/10/2011 on plastic materials and articles intended to come into contact with food.
• Annex II includes Metallic Materials, metals and their alloys that are approved for use in water supply systems, plumbing, and related infrastructure.
• Annex III includes Cementitious Materials, such as cement-based materials.
• Annex IV includes Enamel, Ceramic or Other Inorganic Materials such as non-metallic inorganic materials.

Each entry on the lists has a unique identifier called the EUPL number, which helps monitor, track, and manage approved materials. Every listed substance has also an expiry date for re-evaluation and may include specific condition of use. Migration limit values are also set for substances that may leach into the drinking water.

The first review of the positive lists should be completed within 15 years by the Committee for Risk Assessment (RAC) within ECHA. Based on their evaluation, the European Commission will decide whether to keep, update or remove specific entries.

The Decision enters into force on May 15th, 2024, and applies from Dec. 31st, 2026. Until then, the national provisions continue to apply. Economic operators and national authorities can propose modifications to these lists starting by the end of 2025.

The newly adopted regulatory framework of the Drinking Water Directive not only includes the positive lists mentioned earlier but also encompasses various administrative procedures outlined in additional legislative acts released on April 23, 2024. These procedures cover a range of aspects such as risk assessments, testing methodologies, notification procedures, conformity assessments, EU marking and harmonised specifications.

References and useful links

Understanding the Drinking Water Directive - ECHA

EU Drinking Water Directive

Commission Implementing Decision EU 2024/367

Commission Implementing Decision EU 2024/365

Commission Implementing Decision EU 2024/368

Commission Delegated Regulation EU 2024/369

Commission Delegated Regulation EU 2024/370

Commission Delegated Regulation EU 2024/371