Major Changes in Water Policy Take Flight in the EU

European Drinking Water Directive and the European Positive Lists: What chemical companies need to prepare now

Access to clean drinking water is the primary need for all human beings. Following this, the Drinking Water Directive (EU) 2020/2184 (DWD) of the European Parliament and the Council was recently published, establishing a legal EU framework to protect human health from the adverse effects of drinking water contamination. Of particular interest for chemical manufacturers is Article 11 of the Directive, which sets minimum hygiene requirements for materials that may come into contact with drinking water.

The implications of this Article are far-reaching: for a substance to be used in the manufacture of such a material, its safety must be assessed at the EU level and then included in one of the European Positive Lists (EUPLs) under DWD. Recently, the European Commission adopted the first positive lists of substances that may be used in the manufacture of four types of materials: organic, metallic, cementitious, enamel, ceramic, or other inorganic materials. The first EUPLs were established by drawing largely on the national positive lists previously notified by Member States. This transitional approach allowed continuity at EU level, but it also introduced clear expectations: substances must be re-assessed under harmonized EU criteria if they are to remain authorized.

Hence, while the inclusion of a substance in the EUPL may seem like good news for chemical companies, one should remember that it is not permanent. Each listed substance is assigned an expiry date. Continued use after that date is only possible if the substance is supported by a complete and timely regulatory review, coordinated through the European Chemicals Agency (ECHA). Similarly, the addition of a new substance to EUPL or the removal of an existing entry from EUPL must also be accompanied by the respective regulatory evaluation. The DWD and its implementing acts set clear procedural timelines for the corresponding application process.

Step 1: No notification - no application

Before applying for inclusion, renewal or removal of an entry on EUPL, companies must submit a Notification of Intention (NoI) to ECHA. This requirement is laid down in Commission Delegated Regulation (EU) 2024/369 and further elaborated in ECHA’s guidance. ECHA opened submissions of NoIs via the Industry Portal in January 2026. The NoI must be submitted within 12 months of the application dossier submission. An application without a prior NoI is not admissible.

Step 2: Application – well ahead of expiry date! 

For substances already included in EUPL, a company needs to submit a complete dossier to ECHA at least 18 months before the substance’s expiry date. ECHA's Committee for Risk Assessment (RAC) will review and form opinions on those substances for which a review application has been received. The European Commission will decide, based on the opinion of RAC, if an entry is kept, amended or removed from EUPL. Substances not supported by a timely application dossier will be removed from the list upon expiry. For new substances or removals from the list, companies have 12 months after the NoI to submit the full application dossier. 

What data are necessary for EUPL inclusion? 

The application dossier should be prepared using IUCLID software and must include substance identification, use description, migration data, and toxicological risk assessment in line with the data requirements laid down in the DWD and guidance documents.

Migration testing: Inclusion of a substance in EUPL is risk-driven, meaning only substances that do not pose an unacceptable risk to human health if they leach from the contact material into drinking water may be authorized. Therefore, migration testing should be performed using harmonized methods and under representative worst-case conditions of use to derive a “Calculated Tap Water Concentration” (Ctap). This represents potential human exposure to the substance via drinking water. 

Toxicological information: The extent to which a substance leaches into drinking water determines the toxicological testing required for human safety assessment. Commission Implementing Decision (EU) 2024/365 sets toxicological data requirements under the DWD, using a banded approach based on Ctap values. This approach aims to ensure proportionality while maintaining a high level of health protection. 

While the European chemical legislation (REACH) does not require specific ADME (absorption, distribution, metabolism, and excretion) testing, under Commission Implementing Decision (EU) 2024/365, appropriate toxicokinetic and metabolism studies in mammals can be triggered even at the lowest exposure band, if information available raises a concern for certain human health hazards, e.g., carcinogenicity, reproductive toxicity or endocrine disruption. For the substances in the highest exposure band, the ADME study is compulsory. 

Moreover, a genotoxicity assessment is a core data requirement across all exposure bands. Negative and robust genotoxicity data are a prerequisite for acceptance, as substances migrating into drinking water must not present genotoxic hazards. In addition, for substances with higher Ctap values, repeated-dose toxicity data are required to characterize systemic effects and derive safe exposure levels for humans.  For higher exposure bands, or cases where uncertainties remain, especially regarding mechanisms/modes of action of the substance, high-tier toxicological testing may be required, such as reproductive toxicity or developmental neurotoxicity studies.

Risk assessment: The toxicological data generated are used to derive the Maximum Tolerable Concentration at the tap (MTCtap). In the context of the DWD, the applied-for substance does not pose an unacceptable risk if the Ctap is lower than the corresponding MTCtap. For some substances included in EUPL, the harmonized MTCtap values have already been set and included in Commission Implementing Regulation 2024/367. For these substances, no additional toxicological testing is generally needed, and risk assessment can be performed by comparing Ctap with the existing MTCtap value. 

Strategic implications: What Chemical Companies Need to Prepare Now

The European Positive List system is now operational and time-bound. Companies that align their regulatory strategy with the defined timelines and scientific expectations will be best positioned to maintain access to the EU drinking water market. For chemical companies, the practical implications are clear: they must adhere to the obligations and requirements set by the DWD. The Regulatory Affairs Department is ready to provide consultancy and support for the preparation and submission of all regulatory procedures. Please reach out if you have any questions.

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