Understanding Conformity Assessment and the Declaration of Conformity

Articles 38 and 39 of PPWR require manufacturers to conduct conformity assessments and issue a Declaration of Conformity (DoC) for packaging placed on the European Union market. The DoC is the formal documentation that the packaging complies with applicable PPWR requirements. This lesson explains the relationship among applicable requirements, technical documentation, conformity assessment, and the EU Declaration of Conformity. A DoC is not an isolated certificate. It is the documented result of a conformity process supported by packaging information, evidence, assessment, review, and approval.

From the PPWR general application date, applicable packaging placed on the European Union market needs to be supported by the required conformity documentation. The DoC records the manufacturer’s conclusion that the packaging complies with applicable PPWR requirements. The declaration needs to be supported by appropriate technical documentation.

Technical documentation can include:

• a description of the packaging and its intended use
• packaging structure and material information
• design and manufacturing information
• applicable requirements and assessment methods
• supplier declarations and certificates
• test reports and results
• standards or other specifications used
• assessment conclusions and approvals
• packaging version and validity information

A conformity assessment needs to be connected to the packaging information that has been assessed. Changes in materials, suppliers, structure, intended use, or packaging assignment can affect the evidence or conclusions supporting a declaration.

SAP Responsible Design and Production generates declarations for relevant outbound packaging compositions assigned to products. This solution-processing model supports traceability when a single product has multiple packaging configurations. The legal scope or grouping of documentation should be determined through the organization’s regulatory and legal review, not inferred solely from the software object model.

The next unit explains how SAP Responsible Design and Production connects packaging compositions with products and supports current conformity-documentation and DoC processes.

Conformity documentation needs continuing governance. Organizations should be able to identify the applicable packaging version, the evidence used, the assessment result, the approval, the declaration, and any subsequent changes.

Competent authorities can request technical documentation. Organizations, therefore, need controlled processes for retrieving complete, coherent, and traceable evidence.

• The EU Declaration of Conformity records the manufacturer’s conformity conclusion.
• Technical documentation supports the assessment and declaration.
• Evidence should be connected to the packaging it supports.
• The software packaging-composition model supports traceability but does not by itself determine the legal grouping of documentation.
• Packaging and evidence changes need continuing review and document governance.