What documents do I need for heavy metals and PFAS in my packaging?
The key point is that you cannot declare this yourself without substantiation. For heavy metals (lead, cadmium, mercury and hexavalent chromium) and for PFAS in certain packaging applications, the regulation requires evidence that can be traced back to the materials actually used. This evidence typically consists of two layers: a written statement from your supplier regarding material composition, and where relevant a test report from a laboratory.
For standard packagings such as uncoated cardboard, plain glass or unpainted plastic, this often remains limited to the supplier's statement. For packagings with coatings, inks, closures, grease-resistant laminates or specific barrier layers — think of food packagings with a non-stick coating — the question about PFAS arises more readily, and a laboratory test may indeed be necessary to substantiate the composition.
Why this differs from other documents in the file
With name and address on the packaging or with the structure of the technical file, you assemble the documents yourself: these are data you know and texts you write. With heavy metals and PFAS it is different. You are making a statement about a material you do not yourself manufacture, and the substantiation accordingly belongs with the party that supplies the material. That is the detail that plays most heavily in this topic: you are dependent on your suppliers for these documents, and that dependency is precisely where things often go wrong. A supplier who does not provide a statement, or a statement that only covers the base material and not the added coating or ink, leaves a gap in your file that you cannot fill yourself without asking a supplementary question.
What is asked for in practice
In practice, it concerns a supplier's statement on the material composition of each packaging component, including coatings, inks and closures, not just the primary material. Additionally, a safety data sheet or technical datasheet of the material is often requested, and in case of doubt about a specific substance, a test report from a recognised laboratory in which the concentration of that substance is documented. For packagings that consist of multiple components — a box with a plastic window, or a bottle with a closure of a different material — the substantiation should be built up per component, not as a single statement covering the whole.
How this relates to the technical file and the declaration of conformity
These documents rarely stand alone. They typically form the basis underlying the technical file, and the technical file in turn is the basis for the declaration of conformity in accordance with Annex VIII. Those who reverse this sequence — signing the declaration first and only then gathering the underlying documents — run the risk of making a declaration that is not supported by evidence. In the knowledge base by topic is set out how these documents relate to each other and which location in the official text applies.
When this does not apply
Not every packaging requires this level of detail. For simple, uncoated packaging without additives, the likelihood that heavy metals or PFAS are relevant usually remains limited, and a declaration from the supplier is in most cases sufficient. Whether this also applies to your packaging depends on the material, the coating and the application, and that is precisely where the wizard by packaging type provides an initial indication without requiring you to create an account.
Once you know which documents are relevant, you often also want to know what it costs to keep those documents properly organized on an ongoing basis per country and per packaging line. That overview is available on the page with fees and what it contains. For specific questions about a particular substance or concentration, we cite the guidelines and refer you to the competent supervisory authority or a lawyer; that is not a question we as a platform will answer for you.
Are you unsure whether this applies to your packaging, or would you first like to see which other documents are relevant to your situation? Do the free quick-scan or browse the topics via frequently asked questions about packaging documentation.