In the water contact sector, regulatory compliance for materials intended for contact with drinking water is not only a regulatory requirement, but a strategic requirement to ensure reliability, safety, and competitiveness on the market.
For designers, manufacturers, and distributors of components such as pipes, valves, faucets, fittings, gaskets, and water systems, and for manufacturers of any object or material intended for contact with drinking water, the legislative framework is complex and evolving, due to the progressive regulatory harmonization at the European level with the full implementation of Directive (EU) 2020/2184, the Drinking Water Directive (DWD).
On this page, ICIM Group has identified and made available the main FAQs in the water contact field, to answer the most common questions in a simple but precise way.
1. Scope of the DWD Directive
The Directive applies to all materials and products that, under their intended conditions of use, are in contact with water for human consumption up to the point of delivery. Since in standard domestic installations drinking water reaches the showerhead, the bathtub, and the bidet, these product types are considered subject to the Directive.
This is no longer a voluntary scheme, but a mandatory certification required by Directive (EU) 2020/2184 on drinking water.
The system moves from a national or voluntary framework to a single, mandatory, and EU-wide recognised system, ensuring harmonised requirements for all products in contact with drinking water.
Self-declaration of conformity under DM 174/2004 may still be used (for products that are unchanged in terms of materials, suppliers, and production processes) only during the transitional period (until 31.12.2032), taking into account the entry into force of the 5 µg/l lead limit as defined by Italy.
As noted in a previous answer, in Italy water used for sanitary purposes is also considered potable; therefore, if the water supply to the toilet cistern comes from the drinking water network, the fill valve must comply with the DWD.
Directive (EU) 2020/2184 (Drinking Water Directive – DWD) does not exclude ‘product categories’ in the traditional sense but defines its scope through the type of water and its intended use. The following are therefore implicitly excluded:
• Products used in systems not intended for drinking water (e.g. industrial water);
• Products used downstream of the ‘tap’ where water becomes a food ingredient (e.g. domestic or professional coffee machines);
• Products that do not come into contact with drinking water (e.g. external, structural, or insulating components).
No. Raw materials such as polymer granules or compounds, intermediate products, and products applied on-site are not covered by the Directive, which applies only to finished products.
2. Permitted Materials and Substances (Positive Lists)
To demonstrate the conformity of materials and products in contact with drinking water, organisations must refer to the positive lists established at European level by Commission Implementing Decision (EU) 2024/367. These lists define which substances are authorised for the production of materials intended for drinking water and are divided according to material type.
Only stainless steels included in the European positive list under standards EN 10088 and EN 10283 may be used.
Yes, in the future certain low lead content alloys may be added to the European positive list, but only after a thorough technical assessment and approval by the competent European authorities.
Implementing Decision (EU) 2024/365 sets out the technical and scientific criteria for testing and accepting starting substances, components, and compositions for the renewal of existing positive list entries and the inclusion of new ones.
Yes, certain brass alloys have already been confirmed in the European Positive List (EUPL). It is important to note that the EUPL cannot be modified until 31 December 2026. However, the inclusion of additional brass alloys with a maximum lead content of 0,1% — such as CW511L and CW727R — is expected between 2027 and 2032, provided they meet the new migration limits and are subject to scientific evaluation by ECHA.
The composition of materials used in coatings must comply with the provisions of Implementing Decision 2024/367, which establishes the authorised substances and release limits for metals such as nickel and chromium. If a treatment uses substances not included in the positive list, or substances that are liable to release high levels of potentially toxic metals, it may be considered non-compliant from the outset.
3. Laboratory Testing and Migration Tests
The organization may provide a representative specimen where a component or product is of a size that makes the test impractical. It is important to pay close attention to the preparation of the specimen, and the manufacturing process of the final materials must be clearly specified in the test reports.
It is the responsibility of the certification body to verify the representativeness of the samples, as the geometry — and in particular the thickness — could affect conformity, specifically in relation to the release of substances.
The wetted surface (or contact surface) is the internal surface area actually exposed to drinking water during the product’s normal use. Only the internal surface of pipes, fittings, valves, taps, tanks, membranes, and similar components are taken into account.
Surfaces are expressed in m² or cm², and used to calculate the surface-to-volume ratio (S/V) applied in migration testing.
The tests required by Implementing Decision (EU) 2024/368 are performed on new, representative products to assess the migration of substances under intended conditions of use. However, the regulations do not provide for specific tests on product wear over time.
To ensure that the product remains compliant throughout its service life, the organisation must implement a production control system that guarantees the consistency of material characteristics and the manufacturing process.
If a product is available in multiple sizes, the size to be selected for testing is the one representing the most critical condition in terms of surface area in contact with the water volume (surface-to-volume ratio), as this ratio directly affects the migration of substances.
When performing tests on porcelain enamel coatings according to EN ISO 4531, the test temperature should reflect actual conditions of use; however, as a precautionary measure or in cases of uncertainty, a worst-case temperature may be applied.
Migration tests required to demonstrate the conformity of materials and products in contact with drinking water are performed without the presence of chlorine.
Yes, under certain conditions it is possible for organic materials (such as plastics, elastomers, or coatings) intended for contact with drinking water to generate NIAS (Non-Intentionally Added Substances) at levels that could affect compliance. Some examples:
• PE or PEX materials subjected to hot chlorinated water may generate aldehydes or other oxygenated compounds;
• Polymers containing antioxidants may degrade into toxic by-products;
• Epoxy coatings may generate residual epoxides or reactive amines.
Sampling of products to be tested is carried out by the notified body.
No, because sampling of products to be submitted for testing must be carried out by the notified body.
Tests must be performed by a laboratory selected by the notified body from among those operating in compliance with the requirements of ISO 17025.
4. Certification Process and Assessment Modules
For products falling into higher risk groups, the notified body carries out annual surveillance visits and sampling of contact materials, specifically to verify that production continues to conform to the approved product type. The manufacturer is required in any case to notify the notified body of any changes it intends to make to the approved product or production process.
The Notified Body will assess the technical documents provided by suppliers, the process parameters, and the batch traceability system. A site inspection will also be conducted to confirm that the process is consistent and maintained under control through procedures and operational instructions.
Grouping is possible but requires that the products be homogeneous in terms of material, production process, and conditions of use. The responsibility for ensuring this homogeneity lies with the organisation, which must provide the notified body with all the information necessary for assessment.
Module B concerns the ‘EU type-examination’, which certifies that a representative prototype of the product meets the essential safety requirements set out in the regulations. However, to place the product on the market, it is necessary to ensure that series production maintains conformity with the approved type. For this purpose, Module D focuses on quality assurance of the production process. It requires the manufacturer to implement an approved quality system ensuring that every manufactured product conforms to the type described in the Module B certificate.
In summary, while Module B certifies the product type, Module D ensures that series production conforms to that type, thereby covering the entire process from design to production.
Although precise timelines cannot yet be determined, the certification process is expected to take at least six months.
Under the new EU legislative framework, certificates of conformity to the DWD for products in contact with drinking water cannot be issued before 1 January 2027, as prior to that date no notification can be issued to the conformity assessment bodies designated by Member States. However, conformity assessment bodies that have completed the accreditation process for the DWD certification scheme may begin certification processes before that date, so as to issue certificates promptly once the notification has been received.
The DWD is based on combinations of modules rather than individual modules.. The authorisation system used is the so-called ‘1+’ system, already applied in other European regulations (e.g. CPR), which provides for 3 modules:
• Module B – EU type-examination: verification of the product design and materials;
• Module C – Internal production control: the manufacturer ensures that production conforms to the approved type;
• Module D – Production process quality assurance: quality system certified with oversight by a notified body.
The modules are not used individually but in combination (hence the designation ‘1+’). Module B is always mandatory; depending on the product risk level, it is combined with either Module C or Module D.
Certificates issued by the notified body are valid for 5 years and, for Module D only, provide for annual surveillance.
5. Component Management and Supply Chain
Yes, you may purchase components already certified under Directive (EU) 2020/2184, but this alone does not guarantee the conformity of the finished product. Even if individual components are certified, it is your responsibility as the assembler to verify that the assembled product as a whole complies with the requirements set out in the Directive.
If you are a paint manufacturer seeking to comply with Directive (EU) 2020/2184, you may act as a supplier of coating materials intended to come into contact with drinking water. You are not required to test the finished product, but you must ensure traceability of substances, production quality, and process consistency, so that the notified body can carry out a correct assessment of the material when the paint is applied to a product undergoing certification.
In summary, as a paint manufacturer you can contribute to conformity by providing formulations based on authorised substances, detailed technical documentation, and customer support for the necessary assessments.
You may use that certification subject to verification of the relevant documentation by the Certification Body.
6. Marking, Labelling, and Information
Where the symbol, at the required minimum size, cannot be affixed to the product, it must be affixed to the packaging and included in the documentation.
In the following cases the symbol may be omitted from the product:
• The product is too small to affix the symbol at the required size;
• Products sold as spare parts for assembled products;
• Products made from a material that does not provide adhesion, such as liquid sealants;
• Products whose shape does not allow the symbol to be correctly affixed;
• Products whose function would be impaired by the affixing of the symbol.
The wording ‘suitable for drinking water’ must be stated in the official language or languages of the country in which the product is placed on the market or put into service.
The marking must be affixed in a visible, legible, and indelible manner on the product as well as on the packaging and accompanying documentation. Where affixing on the product is not technically possible, the marking must appear at least on the packaging and in the accompanying documentation.
Standard CE marking is not required; instead, a specific marking defined by EU Regulation 2024/371 applies.
7. Transitional Period and Application Across Countries
From 31.12.2026 until 31.12.2032, each Member State may continue to apply its own national rules, such as existing authorisations, positive lists, or certification systems. During this period, products that comply with national requirements may still be placed on the market, but only in the Member State in which those rules are recognised. The applicable national requirements, including those concerning lead, should therefore be checked in each relevant Member State. For example, in Germany the new lead limit will enter into force on 12.01.2028.
In Germany, the lowered limit value for lead of 5.0 µg/l in drinking water will enter into force on 12 January 2028. From that date until the end of the transitional period, only alloys included in the UBA (Federal Environment Agency) guideline for metals may be used.
Conformity certificates for products made from lead-containing alloys will be limited to 12 January 2028, and a change of materials will require a new product assessment.
This is correct for products that are certified under DWD Certification scheme. Otherwise, products in contact with drinking water may be placed on the market only in member states where their relevant national certification is valid.
Italy has requested a derogation for the application of the new requirements until 2030; we are waiting for a response from the Ministry of Health, which will, if granted, be formalised in the updating decree of Legislative Decree 18/2023, expected in the second half of the current year.
In Italy, the transitional period for placing on the market products that do not meet the 5 µg/l lead requirement in water intended for human consumption has been set at 31 December 2030. From that point, the alloys used must comply with the provisions of the revised Legislative Decree 18/2023.
Only in the Member States in which they were issued.
All metallic materials exceeding the new lead release limits may no longer be used after 31 December 2030 in Italy.
8. Role of Notified Bodies and Laboratories
Future Notified Bodies will be able to start certification processes as soon as they have received accreditation for the DWD scheme, while notification can only be issued from 1 January 2027. Once notification is received, certificates can be issued. ICIM has already obtained accreditation and initiated the first certification processes.
Certification can only be issued once notification has been received, but the certification process under the new scheme may be started in advance. The notification will be visible on the NANDO portal and will be communicated in advance to all clients holding voluntary certification under DM 174/2004.
Yes. For example, OMECO Rende Laboratory has already obtained the necessary accreditations to carry out tests in compliance with the new DWD.
Correct. The system moves from a national or voluntary framework to a single, mandatory, and EU-wide recognised system, ensuring common and uniform requirements for all products in contact with drinking water.
Now that ICIM has obtained accreditation, it is possible to start the certification process, carry out field verification and sampling. The subsequent tests must be carried out by an accredited laboratory in accordance with the applicable requirements.
From 1 January 2027, notified bodies authorised to issue EU certificates under the DWD will be visible on the official European Union database NANDO at the following LINK.