Whoever prepares a declaration of conformity for their packaging must be able to substantiate it. This substantiation is called the technical file, and it is more than just a signature on a form. The file typically contains the product description and material composition of the packaging, the calculation or substantiation of recyclability, test reports or supplier declarations on the materials used, and separate substantiation on substances of concern such as heavy metals and PFAS. It is precisely this last element that is most often overlooked in practice.
The detail that matters most here is that a declaration of conformity without underlying evidence has little value. The regulation requires not only declaring that packaging complies with the essential requirements, but also demonstrating how. For heavy metals and PFAS, it is not about an intention or a purchasing condition with the supplier, but about a concrete declaration with limit values against which the material has been tested. This part is regularly missing, even though it carries more weight than the declaration itself.
What the technical file normally contains
A file begins with a description of the packaging: the material type, the function (sales packaging or transport packaging, with a separate assessment for each), and the weight and volume in relation to the contents. This is followed by substantiation of the essential requirements in Annex II: is the packaging designed for minimisation, is reuse or recycling possible, and on the basis of which standard or test method has this been established. For materials sourced from a supplier, this is often a declaration from that supplier plus the company's own assessment of how the material is applied in practice.
In addition, there must be a section on name and address. The packaging itself, or the accompanying documentation, must be traceable to the responsible party: who is the manufacturer, and where is it established. For packaging produced outside the EU, the question also arises as to who is accountable within the Union. This subject relates to the question of who in your specific situation is considered the manufacturer, and this differs by packaging type and by country in which you supply. see in a few questions which role applies to your packaging provides an initial indication of this, without you needing an account right away.
The substances declaration: the part that is often missing
In addition to the material and design substantiation, the file requires a separate declaration on the presence of heavy metals such as lead, cadmium, mercury and hexavalent chromium, and on PFAS. This is not a tick box on a supplier form, but a declaration that specifically addresses concentrations and limit values. For companies that purchase their packaging from an external printer or packaging producer, this means that this declaration must be requested from the supplier, and that responsibility for the completeness of the file remains with the manufacturer, even if production is outsourced.
This directly relates to why companies sometimes think they are done once the declaration of conformity is signed. It is the opposite: the declaration is the summary, the file behind it is the evidence. Enforcement authorities and, where applicable, marketplaces can request that underlying evidence, not just the declaration itself.
Why this can differ per packaging type
Sales packaging and transport packaging are assessed separately, and this has consequences for which parts are relevant. With sales packaging, it is often about the recyclability of the material in relation to the contents; with a shipping box, the question of empty space and the ratio between packaging and shipped product is more relevant. Those using both types of packaging would be well advised to maintain a separate file for each type rather than one document for the entire packaging stream. go through the knowledge base by packaging topic provides an overview of how this is worked out for each situation.
Where these documents come from and how you keep them up to date
The basis for such documents stems from the official texts themselves, not from an interpretation that differs per advisor. In case of doubt about what applies in a specific situation, the legislation or a lawyer remains the point of reference; a role finder or file tool can structure things, but does not provide a legal judgment in borderline cases. check where the information on this site comes from shows how this is set up at epria.eu.
Compiling and maintaining such a file, including templates for the declaration of conformity and the substances declaration, is part of the paid section of the platform; the indication of which documents are relevant for your packaging type can be viewed for free. see what is included in the subscription and what remains free provides clarity on that.
Do you first want to know whether, and which, documents apply to your packaging before you spend time on a file? The free quick scan provides an initial indication, and the role finder shows which role and which country apply to your situation.