Pre-products

Under the Drinking Water Directive (DWD) 2020/2184 and Implementing Decision (EU) 2024/368, the EU has implemented a conformity assessment system purely about the final product or material.

That creates a problem. Hazards of products in contact with drinking water often begin at the level of pre-products. You may buy materials from suppliers with their own compositions, and depending on this composition, migration testing or additional analysis for relevant substances may be required. Also, all substances in the pre-products must comply with the rules on the EUPL.

Thus we must look at pre-products.

What Are Pre-Products?

• Definition: Any intermediate material or component not yet a final product but intended to be further processed into one.
• Examples in manufacturing:
  • Organic materials: polymer granules, masterbatches, resin compounds.
  • Metallic materials: brass rods, copper billets, stainless steel coils.
  • Cementitious materials: premixed cement powders, additives.
  • Enamels/inorganics: frits, glaze powders.
• These pre-products are made from starting substances or compositions that must already be on the European Positive Lists (EUPL) under 2024/367. These compositions are evaluated in the formulation review of the final product under Module B.

Compliance at Pre-Product level

1. EUPL Verification as part of the formulation review. 
2. Purity and Composition Limits
   • Alot of EUPL ebtrues includes maximum impurity limits
   • These can be verified at the pre-product stage. 
3. Formulation Review
   • You (and your notified body) must have a complete formulation review that includes:
     • All starting substances
     • Their EUPL numbers
     • Purity compliance certificates
   • Any non-listed or non-compliant starting substance makes the pre-product unusable.
   • Other supporting data as required.
   • Having a pre-product certificate ensures less questions at supplier side. 

Practical Example

Scenario: You manufacture brass fittings for drinking water systems.

• You buy brass rods (pre-product) from a supplier.
• The alloy is CW501L-DW, which appears on the EUPL.
• You must verify:
  • The supplier certificate lists CW501L-DW exactly.
  • The alloy’s lead content is within EUPL limits.
  • Any additives or treatments also comply with relevant EUPL entries.
• You keep these documents in your conformity assessment file and they can be a pre-product certificate. 

Now imagine you are a big EU chemical company. You’ve spent years developing a new polymer, optimising the recipe, investing in testing, and protecting it as a trade secret.  Now a customer asks: “We need your full formulation for the new Drinking Water Directive.”  Your instinct? No way.  But without the formulation, your customer cannot complete their Article 11 conformity assessment.  The solution is: pre-product certificates. A Notified Body can certify the pre-product without you revealing trade secrets.  

Reach out to us — we can support with this.

Why This Matters

Even if the final product passes migration testing, if the pre-product contains a non-listed or non-compliant starting substance for example, the notified body will reject your Module B conformity assessment as part of the formulation review. 

Compliance must therefore be designed in from the earliest stages of your supply chain and to support your customers you can support them with pre-product certificates.