Introduction
The implementation of Directive (EU) 2020/2184 has introduced a more harmonised regulatory framework for materials and products intended to come in contact with drinking water throughout EU Member States.
While the European Positive List (EUPL) has received considerable attention as one of the most significant elements of the revised framework, several additional technical concepts serve an equally important role in ensuring regulatory compliance and maintaining a high level of public health protection.
Concepts such as MTCtap, EU-MHR and TCFM constitute key elements of the regulatory framework established under Article 11 of the EU Drinking Water Directive.
Together, these concepts provide the scientific and technical basis for assessing the suitability of materials and products intended to come into contact with drinking water.
A clear understanding of the relationship between these elements is becoming increasingly important for manufacturers, laboratories, conformity assessment bodies and other economic operators involved in the implementation of the harmonised European framework.
The Regulatory Context Behind the New Requirements
The revised EU Drinking Water Directive establishes a harmonised European regulatory framework for assessing materials and products that may influence the quality of water intended for human consumption.
Prior to the adoption of Directive (EU) 2020/2184, Member States operated independent national approval systems that evolved over several decades. Although these systems pursued comparable public health objectives, differences in testing methodologies, acceptance criteria and regulatory requirements created significant complexity for manufacturers seeking to place products on multiple European markets.
Article 11 of the Directive establishes the legal basis for a coordinated European approach designed to ensure that materials and products intended to come into contact with drinking water do not adversely affect human health or drinking water quality.
Within this framework, technical concepts such as MTCtap, EU-MHR and TCFM provide complementary mechanisms for assessing safety, performance and regulatory compliance.
Why Harmonised Compliance Criteria Matter
The quality of drinking water may be influenced by the materials and products encountered throughout treatment, storage and distribution systems.
Throughout its distribution pathway, water may be exposed to substances released from pipes, fittings, valves, coatings, membranes, and filters.
One of the principal challenges for regulators is determining which substances may leach into drinking water and whether their concentrations remain within acceptable limits from a public health perspective.
The harmonised European framework addresses this challenge by establishing common scientific methodologies and regulatory requirements applicable across Member States, thereby reducing differences between national approaches.
This approach supports regulatory consistency, strengthens consumer protection and facilitates the free movement of compliant products within the European internal market.
What Is MTCtap?
Understanding Maximum Tolerable Concentrations at the Tap
MTCtap (Maximum Tolerable Concentrations at the Tap) is a key concept within the European regulatory framework for materials and products intended to come into contact with drinking water.
It establishes the maximum acceptable concentration of specific substances at the consumer’s tap, taking into account the potential migration of substances from materials and products into drinking water under normal conditions of use.
Rather than focusing exclusively on the composition of individual materials, the MTCtap concept considers the potential impact that migrated substances may have on the quality of water intended for human consumption.
Its primary objective is to ensure that drinking water remains safe for consumers throughout the entire supply chain, including after contact with materials, components and products installed within drinking water systems.
The Public Health Perspective
MTCtap values are derived from health-based considerations and represent an important component of the preventive approach established under the Drinking Water Directive.
They are intended to ensure that the migration of substances from materials and products remains below concentrations considered acceptable for the protection of human health.
This reflects one of the fundamental principles of the harmonised European framework: preventing potential risks through the assessment of materials, product design and conformity evaluation rather than addressing contamination after products have already been placed into service.
The Relationship Between MTCtap and Migration Testing
Migration testing represents a fundamental component of the compliance assessment process for materials and products intended to come into contact with drinking water. It identifies and quantifies substances that may migrate from a product into drinking water under specified testing conditions.
The resulting analytical data are subsequently assessed against the relevant regulatory criteria, including the applicable MTCtap values where required.
For manufacturers, a clear understanding of the relationship between MTCtap and migration testing is essential when selecting materials, evaluating product performance and preparing the technical documentation required to demonstrate compliance.
Understanding EU-MHR
What Does EU-MHR Mean?
EU-MHR refers to the harmonised European health-related requirements applicable to the assessment of substances intended for use in materials and products that come into contact with drinking water.
These requirements provide a harmonised basis for evaluating whether the release of substances from materials remains compatible with the protection of human health.
By establishing common assessment principles, the EU-MHR framework contributes to greater consistency in regulatory decision-making across Member States.
Why EU-MHR Is Important
Prior to the introduction of harmonised European requirements, materials accepted in one Member State were not necessarily recognised in another one.
The introduction of EU-MHR supports a more consistent scientific approach by establishing common health-related assessment criteria applicable throughout the European Union.
This contributes not only to regulatory harmonisation but also to increased transparency, greater regulatory certainty and a consistently high level of public health protection.
Practical Implications for Manufacturers
Manufacturers should be aware that compliance extends beyond the use of substances included on the European Positive List.
Depending on their intended application, products may also need to satisfy certain performance and migration requirements.
Consequently, complete set of technical documentation, testing data, and robust risk assessments are essential for demonstrating compliance with the applicable requirements.
What Is TCFM?
TCFM stands for Treatment Chemicals and Filter Media, which includes products used within drinking water treatment processes. This covers substances and materials used to remove contaminants or support treatment performance.
Examples may include treatment chemicals used in purification processes as well as filtration materials employed within treatment systems.
Why TCFM Is Regulated
Treatment chemicals and filter media interact directly with water intended to be used with drinking purposes. Regulators must ensure that these products do not introduce unacceptable risks or adversely affect drinking water quality.
The Drinking Water Directive notes that protecting public health depends on both infrastructure materials and the products and substances used throughout treatment operations.
Compliance Considerations
Manufacturers and suppliers of TCFM products must comply with a range of regulatory requirements. Depending on the product category, they might need to undergo technical evaluation, provide supporting documentation and complete applicable conformity assessment procedures.
The main objective is to ensure that these materials and products do not adversely affect the safety or quality of drinking water.
How MTCtap, EU-MHR and TCFM Work Together
Although these concepts focus on different aspects of compliance, they are closely interconnected. MTCtap gives health references for consumer exposure, while EU-MHR sets harmonised criteria for assessing migration effects.
TCFM requirements apply to products used directly in treating water.
Together, these elements form part of an integrated regulatory framework supporting the implementation of Directive (EU) 2020/2184 and its objective of ensuring a high level of public health protection.
Rather than of working alone, they work in combination to ensure a consistent approach to safeguard public health and keeping regulatory harmonisation across the EU.
Implications for Manufacturers, Laboratories and Conformity Assessment Bodies
The implementation of the harmonised European framework has practical implications for all stakeholders involved in the manufacture, assessment and certification of products intended to come into contact with drinking water.
Manufacturers
Manufacturers are expected to evaluate product formulations, constituent substances and product performance against the applicable European regulatory requirements.
As the regulatory framework continues to evolve, continuous monitoring of legislative developments, implementing acts and technical guidance becomes an essential component of ongoing compliance activities.
Laboratories
Accredited laboratories play a fundamental role in supporting the implementation of the harmonised framework through migration testing, analytical assessments and the generation of reliable scientific data.
The results produced by laboratories provide the technical evidence required to demonstrate compliance with the applicable regulatory requirements.
Conformity Assessment Bodies
Conformity assessment bodies contribute to the implementation of the European regulatory framework by reviewing technical documentation, assessing supporting evidence and verifying compliance with the applicable conformity assessment procedures.
Their activities support the consistent application of harmonised requirements across Member States while strengthening confidence in products intended to come into contact with drinking water throughout the European market.
Challenges Associated with the Transition to Harmonised Requirements
The transition from national approval systems to a harmonised European regulatory framework presents both opportunities and implementation challenges for economic operators.
Manufacturers may be required to review existing product portfolios, reassess legacy formulations and verify that products continue to satisfy the applicable regulatory requirements established under the revised framework.
The availability of supporting scientific data may also represent a challenge, particularly for substances that have been used for many years under previous national approval systems.
Furthermore, organisations operating across multiple jurisdictions are expected to monitor ongoing legislative developments, implementing measures and transitional provisions in order to ensure continued compliance throughout the implementation process.
Despite these challenges, the progressive harmonisation of requirements is expected to reduce regulatory complexity over the long term while promoting greater consistency across the European market.
The Role of DWD-EUPL in the Evolving Regulatory Landscape
As the European regulatory framework continues to evolve, access to reliable technical information is becoming increasingly important.
DWD-EUPL contributes to this objective by providing information and technical resources related to the implementation of the Drinking Water Directive, the European Positive List system and associated compliance requirements.
For stakeholders seeking to understand concepts such as MTCtap, EU-MHR and TCFM, access to accurate and up-to-date information supports informed decision-making, facilitates regulatory compliance and improves understanding of the technical requirements applicable to products intended to come into contact with drinking water.
Key Questions from Industry Stakeholders
What does MTCtap stand for?
MTCtap stands for Maximum Tolerable Concentrations at the Tap and refers to health-based concentration limits used within the European regulatory framework to evaluate the potential migration of substances into drinking water at the consumer’s tap.
What is EU-MHR?
EU-MHR refers to harmonised European requirements associated with migration and health-related assessments for materials intended to come into contact with drinking water.
What does TCFM mean?
TCFM stands for Treatment Chemicals and Filter Media, a category covering products used in drinking water treatment processes.
Why are MTCtap and EU-MHR important?
These concepts provide the scientific and regulatory basis for assessing the migration of substances from materials into drinking water and contribute to maintaining a consistently high level of public health protection throughout the European Union.
Who is affected by these requirements?
The harmonised framework is relevant to manufacturers, suppliers, laboratories, conformity assessment bodies, certification organisations and other economic operators involved in products intended to come into contact with drinking water.
How are these concepts connected to the Drinking Water Directive?
They form part of the broader regulatory framework established under Directive (EU) 2020/2184 to support harmonised assessment of materials and products intended to come into contact with drinking water across the European Union.
Regulatory Outlook and Future Developments
The introduction of MTCtap, EU-MHR and TCFM represents a significant development in the European approach to Drinking Water compliance. These concepts support the objectives of the EU Drinking Water Directive by providing scientific and regulatory mechanisms for assessing materials, substances and products that come in contact with Drinking Water.
As implementation continues across Member States, familiarity with these concepts will become increasingly important for organisations seeking to demonstrate compliance within the harmonised European regulatory framework.
The continued evolution of the DWD-EUPL framework is expected to strengthen regulatory consistency, support public health protection and facilitate the placing of compliant products on the European market through a harmonised European approach based on scientific assessment and regulatory requirements.