The new European system for materials and products in contact with drinking water, set out under Directive (EU) 2020/2184 and its delegated regulations, relies on the New Legislative Framework (NLF) modules for conformity assessment.
Thus, we must introduce how these Modules work.
Before a product can be placed on the EU market, it must undergo an assessment. That assessment must follow a standardised process so manufacturers know exactly what to expect.
These Modules cover the design of your product and its production. The most relevant for DWD are Module B (design) and the follow-up modules C or D (both covering production, but in different ways).
Module B – EU-Type Examination
Module B is the starting point for all products. In this step, a Notified Body evaluates a representative sample of the product — the “type” — to verify that it meets the hygiene, formulation, and migration requirements.
This involves reviewing the formulation against the European Positive Lists, checking technical documentation, and conducting migration testing under CID (EU) 2024/368. If the product passes, the Notified Body issues an EU-Type Examination Certificate. Module B therefore confirms that the design is compliant — but it does not by itself authorise mass production.
Essentially, this step is based on documentation and test reports. The Notified Body reviews your test results, may perform additional testing, assesses documents, and once compliance is demonstrated, issues the certificate.
Module C – Conformity to Type (Internal Production Control)
After Module B approval, one option is Module C. Under this route, the manufacturer is fully responsible for ensuring that all produced units match the approved type. There is no ongoing involvement of the Notified Body after the type approval.
Module C is generally used for lower-risk products (risk groups 3 and 4), where the potential impact on drinking water quality is lower.
For metallic products, if they fall under product group C or D in Table 2 (“Product group for metallic compositions”) of Annex II to Implementing Decision (EU) 2024/365, Module C is also used.
Module D – Conformity to Type (Production Quality Assurance)
Another option following Module B is Module D. Here, the manufacturer must implement a quality assurance system (aligned with ISO 9001 or equivalent), which is audited annually by a Notified Body.
This ensures that production consistently delivers compliant products — not just at the design stage, but throughout mass manufacturing. Module D is required for higher-risk products (risk groups 1 and 2), where stricter oversight is justified due to higher potential impact on drinking water quality.
As part of Module D, the Notified Body also takes production samples for independent verification.
How the Modules Fit Together
In practice, under the DWD every product must first complete Module B type examination, which confirms that the design is compliant.
From there, the path depends on the product’s risk group:
- Lower-risk products → Module C (internal production control)
- Higher-risk products → Module D (production quality assurance)
This layered system provides proportionate oversight, ensures efficiency, and gives manufacturers clear, predictable routes to compliance.