The European Positive Lists (EUPL) at the Core of Directive (EU) 2020/2184

Directive (EU) 2020/2184 establishes a harmonised framework intended to ensure the safety of materials and products that come into contact with water intended for human consumption. To achieve this objective, it introduces a central mechanism: the EUropean Positive Lists (EUPL). These lists now constitute the single reference for determining which substances may be used in drinking water installations, whether pipes, storage tanks, treatment equipment or any other component of the network.

The scope of the EUPL is defined in particular under Article 11(2)(b) and Annex V of the Drinking Water Directive (DWD).

The EUPL: Definition, Role and Scope

The EUPL are unique reference lists that group together the substances, compositions or constituents considered safe for use in contact with drinking water. Their function is essential, as they make it possible to exclude any material likely to alter drinking water quality or present a health risk for consumers. Article 10 of the directive indeed requires that only materials, meaning solids, semi-solids, or liquids used for the manufacturing of a product (an item intended to be placed on the market and coming into contact with water intended for human consumption), listed on these registers may be used in installations. This requirement ensures full harmonisation at the European level and ends the differences in practices that previously existed between Member States.

Categories of Materials Covered

The EUPL, presented in Commission Implementing Decision (EU) 2024/367, cover four major families of materials:

1. Organic materials including polymers, resins and monomers used in their manufacture.

2. Cementitious materials, such as mortars or other cement-based components used notably in reservoirs or hydraulic structures.

3. Metallic materials, including authorised alloys such as copper or stainless steel.

4. Enamels, ceramics and other inorganic materials, which are included for applications requiring coated surfaces or specific components.

For some of these materials, particularly organic and cementitious ones, the evaluation is based on the calculation of the MTCtap (Maximum Tolerable Concentration at the Tap). This threshold represents the maximum acceptable concentration at the point of use, defined either from ECHA opinions or limits set by the European Commission.

The Inclusion Process

The inclusion of a substance in an EUPL is based on a strictly regulated scientific procedure involving a thorough risk assessment, taking into account the potential migration from the material into drinking water under the most unfavourable conditions of use. Conformity tests are then carried out to verify the material’s safety, particularly its impact on organoleptic properties and the microbiological balance of water. When all criteria are deemed satisfactory, the substance may be included in the positive list, following the opinion of ECHA’s Risk Assessment Committee (RAC).

Regulatory Framework and Implementing Decisions

The evaluation procedure is defined by Delegated Regulation (EU) 2024/369, which sets out the information requirements and the modalities for ECHA’s assessment. In parallel, implementing acts establish the test methods used to verify the conformity of substances or compositions.

The application rules of Directive (EU) 2020/2184, notably the establishment of the lists and the testing requirements, are detailed in the following implementing decisions, all dated 23 January 2024:

1. Commission Implementing Decision (EU) 2024/367: Establishes the European positive lists of starting substances, compositions and constituents authorised for use in manufacturing materials or products that come into contact with water intended for human consumption. This document contains the European Positive List.

2. Commission Implementing Decision (EU) 2024/365: Lays down the application rules of the Directive regarding methodologies for testing and accepting starting substances, compositions and constituents for inclusion in the European positive lists.

3. Commission Implementing Decision (EU) 2024/368: Its annexes specify that certain cementitious constituents and certain starting substances may be used without being listed in the European Positive List. This exemption depends on their level of migration and/or hazard. Consequently, information (and potentially testing) on these aspects must be obtained to determine whether the substance must be included in the EUPL.

Dynamic Lists Regularly Updated

The EUPL are not static. They are subject to periodic review to take account of scientific developments, new toxicological data or technological innovations. The first lists currently include 2,042 starting substances, compositions and constituents. Each listed substance must be reassessed at least every fifteen years. The initial European lists will be drawn up from existing national lists, then reviewed by ECHA to ensure compliance with European requirements.

Each entry is associated with an expiration date defined according to the characteristics of the substance and the quality of the initial evaluation. The current deadlines extend to 31 December 2028, 2031, 2034 and 2037. To remain listed, a renewal or re-evaluation request must be submitted 18 months before the expiration date.

Regulatory Procedure: From Notification of Intention to Complete Submission

The evaluation process begins with a Notification of Intention (NoI) submitted via the IUCLID platform. This notification identifies the substance concerned, the associated material category and the type of application (new inclusion, withdrawal or re-evaluation of an already listed substance). The texts provide that NoIs may be submitted from 31 December 2025. The corresponding complete dossiers must then be submitted within twelve months, meaning that the first inclusion or renewal applications may begin as of 31 December 2026.

Strategic Importance for Public Health and Sector Stakeholders

For operators in the sector, the Directive requires constant vigilance in the selection of materials and the verification of their compliance. They must ensure that the products used are listed, anticipate upcoming revisions, and communicate clearly with users regarding the guarantees offered by this regulatory framework.

Conclusion

The European Positive Lists are among the most structuring instruments of Directive (EU) 2020/2184. They ensure a high level of health protection by precisely defining which substances are authorised in drinking water installations. Their implementation is based on robust scientific assessment, regular updates and active cooperation between authorities, manufacturers and operators. For more information, please visit the ECHA website (DWD processes – ECHA) or contact us.

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References:

• Directive (EU) 2020/2184: Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast), OJ L 435, 23.12.2020, pp. 1–62. Available on: http://data.europa.eu/eli/dir/2020/2184/oj (accessed on 01/12/2025).

• Commission Implementing Decision (EU) 2024/367: Commission Implementing Decision (EU) 2024/367 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184, OJ L 2024/367, 23.04.2024. Available at: http://data.europa.eu/eli/dec_impl/2024/367/oj (accessed on 01/12/2025).

• ECHA: European Chemicals Agency, Drinking water directive [online]. Available on: https://echa.europa.eu/water (accessed on 01/12/2025).