The Packaging and Packaging Waste Regulation (PPWR) not only makes the requirements for packaging more specific; it also requires companies to systematically demonstrate their compliance. This brings two terms into focus that are easily confused: Conformity Assessment and the EU Declaration of Conformity.
The two go hand in hand but fulfil different functions. Put simply: the Conformity Assessment is the process for assessing and demonstrating conformity. The EU Declaration of Conformity formally documents the result and the manufacturer’s responsibility.
For companies, this distinction is crucial. PPWR compliance does not end with the question of whether packaging meets the applicable material, design or labelling requirements. Conformity must also be assessed and documented in a traceable manner.
Conformity Assessment: Assessing and demonstrating conformity
Under Articles 15(2) and 38 of the PPWR, manufacturers must carry out, or have carried out on their behalf, the conformity assessment procedure set out in Annex VII before placing packaging on the market. They must also draw up the required technical documentation.
The assessment therefore answers a key question:
Can we demonstrate that this packaging meets the PPWR requirements applicable to it?
To answer this, companies first need to determine which requirements apply to the specific packaging.
Articles 5 to 12 cover, amongst other things, requirements concerning substances in packaging, recyclability, recycled content in plastic packaging, compostability, packaging minimisation, requirements for reusable packaging and labelling. Not every requirement applies in the same way to every packaging type. Companies therefore need to identify the applicable requirements and determine what evidence is necessary to demonstrate conformity. Suppliers also play an important role. Under Article 16, they must provide manufacturers with the information and documentation necessary for manufacturers to demonstrate the conformity of packaging and packaging materials, including relevant technical documentation for the requirements under or pursuant to Articles 5 to 11.
PPWR conformity therefore becomes not only a packaging-design issue, but also a data and documentation task across the supply chain.
Technical Documentation: The evidence behind conformity
The conformity assessment must be supported by the technical documentation required under Annex VII.
In practice, this requires a robust link between:
packaging → applicable PPWR requirement → supporting evidence → assessment result
Depending on the requirement, the evidence may include technical specifications, material and composition information, drawings, calculations, qualitative assessments, test reports or supplier documentation.
Importantly, conformity assessment should not be understood simply as “testing”. Testing may form part of the evidence, but the assessment can draw on different types of technical information and documentation depending on the relevant PPWR requirement.
This creates a particular challenge for companies with large packaging portfolios. It is not enough to collect documents in a decentralised manner. Companies need a structure that makes it possible to trace which evidence relates to which packaging type and which regulatory requirement.
EU Declaration of Conformity: Formally declaring conformity
Once conformity with the applicable requirements has been demonstrated, the manufacturer draws up an EU Declaration of Conformity in accordance with Article 39 and Annex VIII.
The Declaration is therefore not the conformity assessment itself. Rather, it is the manufacturer’s formal declaration that conformity has been demonstrated.
By drawing up the EU Declaration of Conformity, the manufacturer assumes responsibility for the packaging’s compliance with the PPWR.
Annex VIII specifies the information to be included in the Declaration. This includes, amongst other things, identification of the packaging, the manufacturer’s details, the relevant Union legislation and references to applicable standards, common specifications or other technical specifications.
An important practical point is that the declaration is linked to the packaging type. Annex VII provides for a written EU Declaration of Conformity for each packaging type rather than a general company-level declaration of PPWR compliance.
The relationship can therefore be summarised as follows:
Conformity Assessment = assessing and demonstrating conformity.
Technical Documentation = documenting the evidence supporting that assessment.
EU Declaration of Conformity = formally declaring conformity and assuming responsibility.
The question is therefore not: assessment or declaration?
Companies need an end-to-end process that connects the regulatory requirements, the evidence demonstrating compliance and the formal declaration of conformity.
Conformity becomes an ongoing process
PPWR conformity is not a one-off exercise.
Manufacturers must have procedures in place to ensure that series production continues to comply with the Regulation. Changes to packaging design or characteristics, as well as changes to relevant harmonised standards, common specifications or other technical specifications, must be taken into account. Where such changes may affect conformity, the conformity assessment must be reviewed accordingly.
The EU Declaration of Conformity must also be kept continuously up to date.
Documentation must remain available over the longer term. Manufacturers must retain the technical documentation and the EU Declaration of Conformity for five years for single-use packaging and ten years for reusable packaging, calculated from the date on which the packaging is placed on the market.
Conformity management therefore becomes a cross-functional task – spanning packaging and product development, procurement and supplier management, data management, and regulatory and compliance functions.
From individual evidence to a compliance process
Companies should therefore not wait until the declaration stage to start thinking about conformity.
A structured process needs to answer several questions early on:
What packaging types do we have? Which PPWR requirements apply to each of them? What evidence is required? Where does the necessary data come from? How is the evidence linked to the relevant packaging and requirement? Who assesses conformity? And who is responsible for drawing up and maintaining the EU Declaration of Conformity?
This also brings our PPWR series full circle: from understanding the regulatory requirements and their impact on packaging design, data and processes to establishing how companies can ultimately demonstrate, document and formally declare conformity.
The PPWR defines the requirements. The conformity assessment demonstrates whether the applicable requirements are met. The technical documentation provides the supporting evidence. And the EU Declaration of Conformity formally records the manufacturer’s conclusion and responsibility
Need support turning PPWR conformity requirements into a practical process? Get in touch to discuss how to prepare your organisation.