Understanding the Regulatory Framework for Materials in Contact with Drinking Water
The quality and safety of drinking water remain fundamental public health priorities within the European Union. To safeguard consumers and support the effective functioning of the internal market, the European Union has established a regulatory framework designed to ensure consistently high standards for water intended for human consumption.
A major milestone in this regulatory evolution was the adoption of the Directive (EU) 2020/2184 on the quality of water intended for human consumption, known as the EU Drinking Water Directive. The Directive introduced a harmonised European approach to the assessment of materials and products in contact with drinking water, progressively replacing the previously fragmented national systems. One of the key pillars of this framework is the European Positive List (EUPL) which establishes harmonised lists of substances, constituents and starting materials that may be used in the manufacture of products intended to come into contact with drinking water. The EUPL plays a central role in ensuring a consistent level of health protection across the European Union while facilitating the free movement of compliant products within the internal market.
As a result, it is essential for manufacturers, laboratories, conformity assessment bodies and other stakeholders operating within the drinking water sector to understand the relationship between the Drinking Water Directive, the EUPL and the broader DWD-EUPL framework.
This article provides an overview of the current regulatory landscape, explains the role and objectives of the European Positive List, and examines the practical implications of the new framework for companies seeking to place products on the European market.
The EU Drinking Water Directive: A New Regulatory Era
The EU Drinking Water Directive was introduced to modernise the regulatory framework governing drinking water quality and to promote greater consistency among Member States. It not only strengthens public health protection but also improves access to drinking water, and it sets new rules for materials and products used within drinking water supply systems.
Historically, Member States operated individual approval systems for products intended to come into contact with drinking water. Each system was there to protect public health, yet each applied its own testing methodologies and assessment criteria, what results meant, and what approvals were needed.
This fragmented regulatory landscape often created significant administrative and technical challenges for manufacturers seeking access to multiple European markets. Products approved in one Member State frequently required additional supporting evidence before being recognised in other jurisdictions.
The recast Drinking Water Directive was introduced to address these challenges by promoting a more harmonised regulatory approach across the European Union.
Why Materials in Contact with Drinking Water Matter
Materials used throughout drinking water supply systems can have a significant impact on water quality. Pipes, fittings, valves, pumps, coatings, seals, storage tanks, and treatment equipment may release substances into the water. Depending on their composition, such materials may adversely affect public health, organoleptic characteristics, aesthetic quality and compromise compliance with chemical quality requirements established by European legislation. This may also affect consumer confidence in the safety and quality of drinking water.
For this reason, the directive extends its focus beyond water quality itself to include the materials and the products that come in contact with water intended for human consumption. The assessment of these materials constitutes an essential component to making sure the water stays safe and reliable.
From National Systems to European Harmonisation
Prior to the introduction of the harmonised framework, each Member State had its own approval systems for materials and products intended to come in contact with drinking water. Well-known examples include the German UBA system, the French Attestation de Conformité Sanitaire (ACS), the Dutch scheme and the UK regulatory framework, together with several other national systems across Europe.
Although all these schemes pursued the common objective of protecting public health, the absence of harmonised European requirements often resulted in duplication of testing, multiple approval procedures and increased administrative complexity for manufacturers wishing to market their products in more than one Member State.
To address these challenges, the revised Drinking Water Directive establishes a harmonised regulatory framework based on common technical specifications, standardised assessment methodologies and uniform conformity assessment procedures. The objective is to ensure a consistently high level of public health protection while facilitating the free movement of compliant products within the European internal market and reducing unnecessary regulatory barriers to trade.
What Is the European Positive List (EUPL)?
The European Positive List (EUPL) constitutes one of the key elements of the regulatory framework established under the Drinking Water Directive.
The European Positive List is a harmonised inventory of substances, constituents and starting materials authorised for use in the manufacture of products intended to come into contact with drinking water, subject to the conditions, restrictions and technical requirements established by the applicable European legislation.
Rather than serving as a general authorisation mechanism, the EUPL specifies which substances may be used, the conditions under which they may be used and the corresponding regulatory requirements applicable to their use.
The establishment of the European Positive List provides several important regulatory and technical benefits. It enhances regulatory clarity regarding the substances that may be used within the harmonised European framework, promotes consistency in scientific assessments across Member States, contributes to a high level of public health protection, increases regulatory certainty for economic operators and supports the free movement of compliant products within the internal market.
The introduction of the EUPL therefore represents a significant milestone in the ongoing harmonisation of European requirements governing materials and products intended to come into contact with drinking water.
How the EUPL Supports Public Health Protection
The primary objective of the European Positive List is to ensure a high level of public health protection.
Substances contained within materials and products intended to come into contact with drinking water may migrate into water during normal operating conditions.
The extent of this migration may depend on several factors, including material composition, temperature, contact time and the intended conditions of use.
For this reason, substances are subject to a comprehensive scientific assessment before they can be included within the relevant European Positive Lists. The evaluation process takes into consideration toxicological data, chemical identity, anticipated exposure scenarios, migration behaviour and the available scientific evidence relating to potential risks to human health.
Only substances that satisfy the applicable regulatory and scientific assessment criteria may be incorporated into materials and products intended to come into contact with drinking water.
Categories of Materials Covered by the European Framework
The harmonised European regulatory framework applies to several categories of materials commonly used in drinking water systems, each subject to specific assessment criteria intended to ensure that materials and products do not adversely affect the quality of water intended for human consumption.
Organic materials, including plastics, elastomers, coatings and adhesives, represent one of the principal material groups covered by the harmonised framework and are widely used throughout drinking water distribution systems, ranging from pipes and fittings to protective coatings and sealing components, with particular attention paid to their chemical composition, the substances used during manufacture and their potential to release constituents into drinking water under normal conditions of use.
Metallic materials constitute another essential category within the European regulatory framework and are extensively used in pipes, valves, fittings and other components of drinking water infrastructure, with applicable requirements intended to ensure that they do not release substances at concentrations that could adversely affect drinking water quality or compromise the protection of human health, while harmonised assessment methodologies contribute to consistent evaluations across Member States.
Cementitious materials, including concrete, mortar and related construction products, are widely used in drinking water storage, treatment and distribution infrastructure and are assessed using dedicated methodologies designed to evaluate their long-term interaction with water intended for human consumption, with particular consideration given to their potential influence on water quality throughout their expected service life.
Ceramics and other inorganic materials are also included within the scope of the harmonised European framework and, although they generally exhibit a high degree of chemical stability, they remain subject to specific assessment procedures to verify their suitability for continuous contact with drinking water and to ensure compliance with the applicable regulatory requirements.
The DWD-EUPL
The term DWD-EUPL is increasingly associated with the evolving European regulatory framework established under Directive (EU) 2020/2184.
DWD-EUPL encompasses the developing body of regulatory requirements, European Positive Lists, scientific assessment methodologies and conformity assessment procedures supporting the implementation of Article 11 of the Drinking Water Directive.
As additional implementing acts, delegated acts, technical guidance documents and scientific opinions are adopted at European level, the DWD-EUPL framework continues to evolve. Consequently, DWD-EUPL is becoming an increasingly valuable technical and regulatory reference for manufacturers, laboratories, conformity assessment bodies and other economic operators involved in products intended to come into contact with drinking water.
Testing and Compliance Requirements
The inclusion of a substance within the European Positive List represents only one element of the overall compliance process.
Manufacturers are also required to demonstrate that finished products comply with the applicable regulatory and technical requirements, including:
- migration testing
- verification of material composition
- product performance requirements
- implementation of appropriate quality management procedures
- preparation and maintenance of technical documentation
- conformity assessment procedures, where applicable
Implications for Manufacturers and Economic Operators
The transition towards a harmonised European framework presents compliance obligations for economic operators. Manufacturers need to monitor:
- positive list updates
- substance approvals
- testing requirements
- technical specifications
- certification pathways
- transitional setups
A proactive understanding of regulatory developments enables organisations to prepare effectively for future compliance requirements and market expectations. For companies working across borders, this standardized method could simplify processes, reduce regulatory complexity and facilitate broader market access across the European Union.
Future Developments of the European Positive List
The rules governing about the European Positive List are evolving as they are implemented. Continuous updates are expected in areas such as substance evaluations, scientific assessments, technical guidance, testing methods, compliance procedures, and harmonised standards. The overarching goal is to establish a solid and transparent system that protects public health while ensuring consistent regulatory alignment across all Member States.
Key Questions from Industry Stakeholders
What does EUPL stand for?
EUPL is the European Positive List, which is a harmonised list of authorised substances used in materials and products that come in contact with drinking water in Europe. It forms part of the EU regulatory rules governing the safety of materials intended to be in contact with drinking water.
What is the purpose of the EU Drinking Water Directive?
It aims to ensure drinking water is safe and protect public health. The Directive establishes requirements for materials and products used within drinking water systems, ensuring all components in contact with water meet the necessary quality and safety standards
Why was the European Positive List introduced?
The EUPL was created to help standardize rules and offer a reliable scientific foundation for evaluating substances used in drinking water applications.
Which materials are covered by the framework?
The framework covers a wide range of materials, including organic and metallic materials, as well as cementitious, enamel, and ceramic materials. It also applies to any other materials that may come into contact with drinking water.
What does DWD-EUPL refer to?
It refers to the regulatory framework established to ensure drinking water is safe. This is based on the Drinking Water Directive and the European Positive List.
Who should monitor developments related to the EUPL?
Manufacturers, laboratories, certification bodies, consultants, utilities, and any other companies involved in the drinking water systems need to monitor the evolution of the regulatory framework
Regulatory Outlook and Future Developments
The revised EU Drinking Water Directive represents a significant step towards the harmonisation of European requirements governing materials intended to come into contact with drinking water.
As the directive is implemented, its link to the EUPL will become increasingly important to manufacturers, laboratories, and regulatory professionals. A clear understanding of these changes is essential to ensure compliance, supporting public health protection and reinforcing confidence in drinking water systems across the European Union.