For decades, European legislation has successfully protected public health by setting strict quality standards for drinking water. However, today’s challenges are different from the previous ones.
Scientific progress has greatly improved our understanding of how contaminants behave in the environment, while increasing attention has been given to emerging substances such as PFAS, endocrine-disrupting chemicals and microplastics.
The revised Drinking Water Directive (EU) 2020/2184 (DWD) reflects this evolution.
The Directive introduces a comprehensive risk-based approach covering the entire drinking water supply chain, rather than focusing only on compliance at the consumer’s tap.
The risk based approach starts with the protection of water sources and treatment processes and ends with distribution systems – including products that come into contact with drinking water.
This directive represents a shift from monitoring water quality to preventing contamination at its source, introducing new responsibilities for competent authorities, manufacturers, water suppliers and economic operators throughout Europe.
The two pillars of the new framework
The revised Directive strengthens monitoring requirements by providing for new criteria for several emerging contaminants, including PFAS, beta-estradiol and nonylphenol.
Moreover, there are two complementary provisions, Article 11 and Article 12, which establish a harmonized framework for controlling materials and products that come into contact with drinking water for the first time.
Together, they ensure that drinking water remains safe not only because it is monitored, but also by appropriate assessment of every chemical and material that is in contact with it.
Article 11: Harmonising materials in contact with drinking water
Article 11 applies to materials and products used in the abstraction, treatment, storage and distribution of drinking water, such as pipes, fittings, valves, tanks and other infrastructure components.
Its objective is simple yet ambitious: one standard, one test, one market.
Manufacturers will progressively rely on a harmonised European framework, instead of following different national systems. This will reduce regulatory fragmentation while maintaining a high level of public health standards.
This system, developed with the scientific support of ECHA, is based on four key elements:
- European Positive Lists of authorized starting substances, compositions and constituents;
- Harmonized risk assessment methodologies;
- Common information requirements for new applications;
- Transparent procedures for updating the Positive Lists depending on changes in scientific data.
For manufacturers of drinking water contact materials, this represents an important change. The creation of reliable scientific dossiers using IUCLID will definitely become a crucial step toward compliance and market access within the EU.
EU implementation: Article 11 Deadlines
In detail the key dates include:
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12 January 2021
The revised Drinking Water Directive enters into force, introducing a new risk-based approach to drinking water safety. -
23 April 2024
The European Commission publishes the implementing acts defining the European Positive Lists, information requirements, risk assessment methodologies and administrative procedures. -
5 January 2026
Economic operators and Member States can begin notifying ECHA of their intention to submit proposals for adding, amending or removing entries from the European Positive Lists. -
31 December 2026
Two important milestones are reached:- the first European Positive Lists become applicable;
- companies can begin submitting full applications to ECHA to add, amend or remove entries from the Positive Lists.
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31 January 2032
The European Commission will review the implementation of the revised Drinking Water Directive and evaluate whether further improvements are needed. -
31 December 2032
The transitional provisions expire for substances that had previously been approved by Member States during the transition period between 13 July 2021 and 31 December 2026.
What’s next for manufacturers?
Although the first European Positive Lists will only become fully operational at the end of 2026, companies should prepare themselves for this deadline.
Manufacturers need to begin evaluating their portfolio to determine whether the substances used in their drinking water contact materials are already included in the European Positive Lists or whether a future application to ECHA may be required.
Where additional data is needed, early planning will be essential to generate the scientific evidence required for an IUCLID submission.
Taking these steps now will help avoid delays once the European system becomes fully operational.
Article 12: Treatment chemicals and filter media
Whereas Article 11 adresses construction material, Article 12 regulates treatment chemicals (reagents) and filter media used during drinking water treatment.
These products play a critical role for usuring and maintaining water quality; however, since they are intentionally added to water or directly interact with it, they require particularly rigorous health-based oversight.
Unlike Article 11, which is largely harmonized at EU level, Article 12 is implemented by the individual Member State.
In Italy, both products are collectively known as ReMaF, and their authorization is regulated through Legislative Decree 18/2023, recently updated by Legislative Decree 102/2025.
The Italian framework involves several public authorities:
- CeNSiA (National Centre for Water Safety), responsible for product authorizations;
- ASL, responsible for inspections and market surveillance;
- USMAF, overseeing imports from non-EU countries.
To support this system, Italy has also developed the AnTeA Platform, which hosts the national ReMaF Database, ensuring product registration, traceability and transparency throughout the market.
Italian implementation: Article 12 Deadlines
Italy has established its national implementation through Legislative Decree 18/2023 and Legislative Decree 102/2025.
The key deadlines are:
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13 January 2026
- Opening of the national ReMaF authorization procedure through the AnTeA platform.
- Beginning of market surveillance by the competent authorities.
- Application of the new drinking water limits for PFAS, Bisphenol A and chlorate.
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12 January 2028
Existing ReMaF products already on the market (excluding products subject to specific sectoral legislation) must have entered the authorization process. -
13 January 2036
Only ReMaF products authorised by CeNSiA, registered in the national ReMaF Database and correctly labelled may be placed on the market or used in drinking water systems.
This is also the deadline for compliance with the stricter limit value for lead (5 μg/L). -
12 January 2037
End of the transitional period for products already placed on the market before the mandatory implementation date.
How should companies prepare?
The implementation process in Italy has created a new authorization pathway for producers and distributors of treatment chemicals and filter media.
The companies should start assessing whether their products fall within the scope of the ReMaF framework and plan the activities required for compliance, including certification where applicable, preparation of the technical documentation, CeNSiA authorization and registration in the AnTeA platform.
Considering the long implementation timeline, early preparation will provide an opportunity to spread the workload and avoid regulatory bottlenecks as the mandatory deadlines approach.
Looking ahead
The revised Drinking Water Directive is revolutionizing the regulation of drinking water safety in Europe.
While the process of its implementation will continue over the coming years, the regulatory direction is already clear: greater harmonization at European level, improved scientific assessment and increased accountability for manufacturers placing products on the market.
Companies that start preparation now will be in a better position when the new regulations come into effect.
At Chemsafe, our combined expertise in regulatory affairs, toxicology and European chemicals legislation knowledge help us assist manufacturers in complying with both Article 11 and Article 12.
Our Chemical BU Head, Francesca, has extensive experience in the area of drinking water safety. It was the focus of her PhD research, which she expanded with research activities at the U.S. Environmental Protection Agency (US EPA).
Whether you are preparing an ECHA submission, assessing substances for inclusion in the European Positive Lists or navigating the Italian ReMaF authorization system, our company can help you.
Just contact us to get your compliance strategy ready to use.
