Ensuring safe and compliant materials for drinking water across Europe
As part of our commitment to protect human health and promote sustainable regulatory compliance, ARCHE Consulting offers support for companies navigating the requirements of the EU Drinking Water Directive (Directive (EU) 2020/2184).
The Drinking Water Directive (DWD) introduces a harmonised framework for materials and products intended to come into contact with water intended for human consumption. This encompasses materials used in the abstraction, treatment, storage, and distribution of drinking water.
A key element of the regulation is the development of European positive lists, defining which starting substances, compositions, and materials are permitted for use across all EU Member States.
Our team of regulatory and scientific experts is here to support industry actors throughout the entire process, from strategic planning and dossier preparation to laboratory testing, consortium coordination, and follow-up with ECHA.
Why this matters
The revised DWD sets in motion a new and ambitious regulatory pathway for substances used in manufacturing materials that come into contact with drinking water, from the water source to the tap.
The European Positive Lists consolidate national authorisations and establish a harmonised approach across all EU Member States. Each listed substance has an assigned expiry date (end 2028, 2031, 2034, or 2037) based on the robustness of available data and risk assessments. To maintain a substance on the list beyond its expiry date, companies must submit a notification of intention, followed by a review application. If no application is submitted, the substance will be automatically removed upon expiry and will no longer be allowed to be in contact with drinking water. Starting in 2026, industry stakeholders can submit applications to add new substances or amend existing entries.
For manufacturers, suppliers, and users of materials in contact with drinking water, these positive lists represent both a regulatory requirement and a strategic checkpoint. Ensuring relevant substances are listed, with all intended uses identified - and preparing in advance for renewals - is essential to maintaining market access and avoiding compliance disruptions in the coming years.
What sets us apart
ARCHE Consulting brings a unique combination of regulatory insight, scientific depth, and industry involvement:
- Direct involvement in ECHA’s DWD expert discussions, allowing us to anticipate regulatory expectations and align dossiers accordingly.
- Extensive experience conducting risk assessments under REACH and BPR, ensuring scientific robustness and regulatory compliance.
- Expertise in support with migration testing, including transformation dissolution (TDp) testing, critical for demonstrating compliance with DWD requirements.
- Specialised know-how in multi-metallic materials, making us a valuable partner for complex submissions involving metallic alloys and compounds.
Our Drinking Water Directive services:
Strategic advice & regulatory planning
We help clients understand their obligations under the DWD and define the most efficient regulatory path, including:
Substance status verification
Data gap analysis
Timeline and cost planning
Support for notification & submission to ECHA
We assist with the entire application process, including:
Preparation of notification of intention, required prior to submission
Dossier preparation in IUCLID format, in line with ECHA guidance
Exposure and risk assessment, as required under the DWD and relevant implementing acts
Consortium formation & management
When multiple stakeholders share interest in the same substance or material:
We facilitate the formation of effective consortia
Support data sharing and cost-sharing agreements
Coordinate communication and dossier development among members
Laboratory testing strategy & study monitoring
Compliance often requires robust and targeted testing:
We help design testing strategies based on DWD-specific requirements
Coordinate studies with accredited laboratories and perform the study monitoring
Close follow up with testing laboratories to support designing testing strategies accounting for material specificities while complying with EU methodologies identified by the implementing decisions
Technical review and data validation
Follow-up and dossier maintenance
Our team offers long-term support to stay compliant:
Responding to ECHA requests
Monitoring regulatory developments and advising on dossier updates
Helping clients remain fully compliant over time
At ARCHE Consulting, we combine regulatory expertise with in-depth scientific knowledge to help our clients meet evolving legal requirements with confidence. Whether you are a material producer, downstream user, or part of a wider supply chain, we are ready to support your compliance journey under the Drinking Water Directive.
Get in touch with our team to discuss your strategy or upcoming application.
Federica Iaccino
Regulatory Affairs Manager
federica.iaccino@arche-consulting.be
+32 16 28 49 02
Nora Ferencz
Senior Project Scientist
nora.ferencz@arche-consulting.be
+ 32 9 216 70 62