The EU Drinking Water Directive (Directive (EU) 2020/2184) introduces a harmonised framework for materials and products in contact with drinking water. Listing on the European Positive List (EUPL) is now the prerequisite for placing such materials on the EU market. 

The stakes are concrete and time-bound:  

  • Substances not (yet) listed on the EUPL are at risk - without an application to be listed in the EUPL, upon expiry of the national transitional period they will be no longer eligible for use in contact with drinking water. 
  • Substances already listed with near-term expiry dates (e.g. 2028) must apply for renewal by July 2027 to ensure market continuity, renewal proposal applications shall be prepared and submitted to maintain substances on the EUPL. 
  • From 2026, new entries can be applied for by submitting a notification and further on an application to propose addition to the EUPL. 

For manufacturers, suppliers, and downstream users of materials in contact with drinking water, the European Positive List is both a regulatory obligation and a strategic checkpoint. Acting early - with all intended uses correctly identified and renewals prepared in advance - is essential to maintaining market access and avoiding compliance disruption in the coming years. 

Why choose ARCHE Consulting

We combine regulatory insight, scientific depth, and direct industry involvement: 

  • A seat at the table. Direct involvement in ECHA IT tools user group expert discussions, allowing us to anticipate regulatory expectations and align dossiers accordingly. 
  • Scientific rigour where it counts. In-house expertise across identification, hazard assessment, and exposure/migration to build dossiers that hold up to evaluation. 
  • Hands-on lab coordination. Close follow-up with testing laboratories to ensure testing strategies that account for material specificities while complying with the EU methodologies set out in the implementing decisions. 
  • European Representative possibility. For the applicants that are not established in the Union, ARCHE Consulting offers to act as the EU representative legal entity. 
  • Facilitating multi-company initiatives and collaborative application development (including consortium set up, technical support and consortium management). We support collaborative regulatory initiatives involving multiple companies by ensuring efficient governance, transparent decision-making, fair cost-sharing arrangements and timely delivery of regulatory objectives.

Whether you are a material producer, downstream user, or part of a wider supply chain, we support your full compliance journey under the DWD. 

Our approach: four key workstreams, one common factor

We structure every DWD engagement around a clear sequence that aligns strategy, evidence and regulatory delivery - ensuring nothing critical is overlooked, and that timelines dependent on external parties are anticipated and planned well ahead.

01 - Portfolio strategic plan 

Prioritise assets, milestones, and regulatory pathways. 

We start by mapping where you stand. That means building a full in-house inventory of your DWD-relevant materials to prioritise action and set realistic timelines, identifying which entries are at risk, due for renewal, or eligible as new listings - and pinpointing economic operators who may share an interest in the same application. 

02 - Risk assessment

Assess hazards, exposure, uncertainties, and mitigation needs. 

Each DWD application is, at its core, a human health risk assessment demonstrating the safe use of a specific applied-for entry. Many steps do not depend on in-house information alone: hazard assessment may require retrieving physico-chemical and toxicological data or running new tests, and exposure assessment requires an accredited laboratory for the relevant material group. Identifying these milestones early is decisive for staying on schedule. 

03 - Data generation & retrieval

Identify gaps, retrieve existing evidence, and generate missing data. 

Specific data are required to meet the DWD application requirements and demonstrate acceptable risk for every group of applied-for entries. Data generation across identification, hazard assessment, exposure/migration, and risk analysis must follow the relevant guidance documents and quality standards. We clarify the requirements specific to each applied-for entry group at every step, and work consistently across similar entries to maximise efficiency and the likelihood of a successful application. 

04 - Data submission

Manage timing, completeness checks, and submission readiness. 

Reporting each assessment step is as important as the assessment itself. Every DWD dossier must follow specific reporting requirements and be submitted via the IUCLID tool. We help you allocate sufficient time to set up the dossier and ensure all fields are duly completed and backed by testing reports - so the submission is right the first time. 

The common factor: joining efforts across industries and ensure compliance efficiently

Across all four workstreams, one lever consistently improving outcomes is collaboration: joint efforts boost communication with economic operators and ensure a scientific yet strategic approach. 

Where several operators share an interest in the same applied-for entry or in similar applied-for entry, working together can streamline assessment, data gathering, and dossier reporting - for example through shared hazard templates, data sharing agreements and common use questionnaires. The result is a more efficient route to listing, with costs and effort distributed across the parties that benefit. This could potentially lead to a joint application that will have more chances for quick successful assessment. Alternatively, when similar separate applications will be needed, having economic operators working together will allow us to set up the best approach for assessing migration levels and for planning applications submission.  

We help you investigate whether a joint application is the right path: identifying potential partners, scoping the shared work, and quantifying the efficiency gains before you commit. 

Let's discuss your DWD strategy

Get in touch with our experts to discuss your strategy or an upcoming application