Introducing: The (Recast) EU DWD, and article 11 - a new system for products and materials in contact with drinking water

For years, getting a product approved for contact with drinking water in Europe meant juggling multiple national approval systems – and possibly even also different bodies.

A sanitary tap approved in Germany under KTW-BWGL still needed ACS in France, WRAS in the UK, and others elsewhere.

Cost impact: Hygienic certification could make up 15–25% of total certification expenses, with complex assemblies costing tens of thousands of euros per country.

This all led to slower product launches, duplicated testing, and higher overall market entry costs.

The 4MS Initiative – originally led by Germany, France, the Netherlands, and the UK (later joined by Denmark) – was an important step toward harmonising approvals for products and materials in contact with drinking water. It aligned many technical requirements across those participating Member States, most notably through common positive lists for metallic and organic materials and shared testing protocols.

For manufacturers, it reduced some duplication between those countries, but it was never an EU-wide solution. Participation was voluntary, not all material types were fully harmonised, and several major markets still maintained their own national schemes.

The recast Drinking Water Directive’s Article 11 builds on the technical groundwork laid by the 4MS but goes much further, replacing the patchwork with a mandatory, legally binding system that applies in all EU Member States.

The recast Drinking Water Directive (EU) 2020/2184, adopted December 2020, changes that. It is the most significant update since 1998, and it:

• Creates one harmonised EU approval system for products and materials in contact with drinking water.
• Brings stricter safety and quality requirements for water across the EU.
• Embeds a risk-based approach from water source to tap.

Wider Reforms Beyond Article 11

The Directive is about more than materials regulation. It also:

• Reduces the lead limit from 10 µg/L to 5 µg/L at the tap (by 2036).
• Sets limits for bisphenol A, certain PFAS, and other emerging contaminants.
• Adds Legionella monitoring to microbiological checks.
• Expands transparency rules so consumers can see water quality data.
• Introduces measures to ensure safe water access for vulnerable groups.

See at the bottom of this page for an overview.

Article 11 – The New EU-Wide System

From 31 December 2026, Article 11 will replace national approval schemes with a fully harmonised process. Materials must from a general legal point of view:

• Not compromise human health (directly or indirectly).
• Not impair taste, odour, or colour.
• Not encourage microbial growth.
• Not leach contaminants beyond what is necessary.

And to achieve this, Article 11 establishes an EU-wide framework replacing national systems such as KTW-BWGL.

The Four Pillars of the New Article 11 Framework

1. European Positive Lists

   • Approved starting substances, compositions, and constituents.
   • Includes migration limits, conditions of use, and expiry dates.
   • Based on 4MS and materials already used across the EU.

2. Testing & Acceptance Criteria

   • Harmonised EU test methods for final materials.
   • Risk-based approach for proportionate testing.

3. Conformity Assessment & EU Declaration

   • Accredited Notified Bodies.
   • One EU Declaration of Conformity valid in all Member States.

4. Harmonised EU Marking

   • Single EU compliance mark for visibility and enforcement.

So in short: one approval, valid across the entire Union.

With one approval, you are safe for the Union.

Transition & Strategic Takeaways

• National systems remain until 31 Dec 2026.
• Products approved nationally July 2021 – Dec 2026 get grace until end 2032 if they meet the 5 µg/L lead limit.

Bottom line: The recast DWD ends the patchwork approval model and creates a single EU market for water-contact products. It means fewer duplicate tests, faster access, and higher safety expectations. Early movers will benefit most as 2026 approaches.

Act now:

• Perform an impact assessment (we can perform this for you).
• Audit materials against EU Positive Lists.
• Update testing protocols to EU methods.
• Prepare product and packaging for new EU marking.
• Begin preparations for Notified Body conformity assessment.

Annex – Old vs. New: Approvals for Products & Materials in Contact with Drinking Water