Certification of drinking water contact materials under European legislation

Since the 1980s, the European Union has pursued a process of harmonising legislation concerning materials and products intended for contact with drinking water, with the aim of ensuring a high level of public health protection and reducing administrative burdens for companies operating within the European market.

This regulatory process was further consolidated with the publication of Directive (EU) 2020/2184 of 16 December 2020, on the quality of water intended for human consumption, known as the Drinking Water Directive (DWD), which was transposed into Italian law by Legislative Decree 18/2023.

Article 11 of the Directive establishes that materials used in installations for the abstraction, treatment, storage or distribution of drinking water must ensure that:

• human health protection is not compromised
• the colour, odour or taste of the water is not adversely affected
• microbial growth is not promoted
• contaminants are not released into the water at levels higher than necessary for the intended purpose of the material

When the new legislation enters into force

For new products, the European provisions will apply from 31 December 2026.

For products already placed on the market that comply with national requirements and hold certificates valid on 31 December 2026, full application of the legislation is expected by 31 December 2032.

How product certification works

The certification of materials and products intended for contact with drinking water involves a conformity assessment procedure involving several parties.

The process generally consists of the following stages:

1. Verification of the substances used

The manufacturer must verify that the substances used in the production of the material are included in the European positive lists.

2. Assessment of the manufacturing process

The manufacturing processes and treatments applied to the material must be assessed, for example welding, surface treatments or coatings.

3. Laboratory testing

The product undergoes migration testing and chemical analyses to assess the release of substances into drinking water.

4. Assessment by the notified body

A notified body assesses the technical documentation, test results and manufacturing process.

5. EU Declaration of Conformity

Once the procedure has been completed, the manufacturer issues the EU Declaration of Conformity, allowing the product to be placed on the market throughout the Member States of the European Union.

The role of notified bodies

Notified bodies are organisations authorised by the Member States and registered with the European Commission to carry out conformity assessment activities.

They must be accredited by a national accreditation body in accordance with Regulation (EC) No 765/2008.

The notified body verifies:

• the materials used
• suppliers
• the manufacturing process
• product compliance with regulatory requirements

Material groups and positive lists

European legislation provides for the establishment of positive lists of authorised substances for the manufacture of drinking water contact materials.

More than 2,000 substances have currently been approved and are classified according to the type of material:

• organic materials
• cementitious materials
• metallic materials
• ceramic materials and enamels

For each substance, the following are established:

• release limits (MTCtap)
• conditions of use
• permitted impurities
• duration of approval

The role of testing laboratories

Notified bodies appoint testing laboratories accredited in accordance with EN ISO/IEC 17025:2017 to perform the analyses required for conformity assessment.

The Comie laboratory is accredited for all analytical methods required by Commission Implementing Decision (EU) 2024/368, enabling manufacturers to carry out the entire testing programme required for the certification of drinking water contact materials at a single laboratory.