I. Compliance Assessment Process under the PPWR
According to Article 38 of the Regulation (EU) 2025/40 on Packaging and Packaging Waste (PPWR), a Conformity Assessment of packaging shall be carried out as regards the requirements laid down in Articles 5 to 12, in accordance with the procedure described in Annex VII of the PPWR.
According to Annex VII of the PPWR, it shall be possible to assess the packaging’s conformity with the applicable requirements. For this purpose, the manufacturer shall establish Technical Documentation, consisting of the following:
- General description of the packaging and what it is intended to be used for.
- Design information, manufacturing drawings, and details of the materials used for the packaging and its components.
- Any necessary explanations of drawings, diagrams and how the packaging is designed.
- One or more lists identifying:
o Harmonized standards (Article 36) as applied either fully or partly.
o Common specifications (Article 37) as applied either fully or partly.
o Other relevant technical specifications used for measurements or calculations.
o If harmonized standards or common specifications were only applied in part, a description of which parts were used.
o If required harmonized standards or common specifications were not used, an explanation of the alternative solutions adopted to meet the applicable requirements. - Qualitative description of how the assessments required under Articles 6, 10, and 11 were carried out.
- Test reports supporting PPWR compliance of the packaging.
Furthermore, according to Article 39 of the PPWR, the manufacturer must set up a Declaration of Conformity (DoC) which must be available in the language required by the Member State in which the packaging is made available on the market.
The DoC should indicate the relevant EU laws and their official references and can also include several individual declarations collected in one file, for example referring to different parts of the same assembled product packaging, etc. By signing the DoC, the manufacturer confirms that the packaging meets the applicable legal requirements and accepts responsibility for its compliance.
According to Annex VII of the PPWR (Module A), the manufacturer shall draw up DoCs for each packaging type and keep it together with the technical documentation at the disposal of the national authorities for the periods specified in Annex VII of Regulation (EU) 2025/40.
According to Annex VIII, the content of the DoC is specified as follows:
- Statement of fulfilment of the requirements laid down in Articles 5 to 12.
- Information provided via the model structure set out in Annex VIII:
1. Unique packaging identification: Clear reference or code that identifies the packaging covered by the DoC.
2. Manufacturer details: Name and address of the manufacturer and, if applicable, their authorized representative (AR) according to Article 17. The appointment of an AR under Article 17 is voluntary unless otherwise required by specific contractual arrangements.
3. Declaration of manufacturer responsibility: The manufacturer takes full responsibility for this declaration and for the packaging meeting the applicable requirements, in particular Regulation (EU) 2025/40 (PPWR).
4. Packaging description: A description of the packaging that allows it to be clearly identified and traced.
5. Compliance statement: A clear statement confirming that the packaging complies with the applicable EU legislation, in particular Articles 5-12.
6. Reference to Applicable Standards: A list of the standards, specifications, or technical requirements used to demonstrate compliance.
7. Reference to Third-party assessment (if applicable): Details of any notified body or other entity that assessed the packaging and any certificates issued.
8. Additional information and signature: Any additional information, plus the place and date of issue, the name and position of the responsible entity, and their signature.
The manufacturer’s obligation of keeping the Technical Documentation and Declaration of Conformity may be fulfilled by its Authorized Representative (Article 17 PPWR), on its behalf and under its responsibility, provided that those obligations are specified in the mandate.
II. Declaration of Conformity: What Manufacturers Need to Include
1.Unique packaging Identification
The declaration must contain a unique identifier that allows the packaging covered by the declaration to be clearly identified.
This may include:
- Packaging type number
- Packaging model reference
- Packaging specification number
- Packaging family identification
The objective is full traceability between the declaration and the physical packaging.
2. Manufacturer details
The declaration must identify the manufacturer responsible. This should include:
- Company name
- Full address
- Contact information where appropriate
3. Manufacturer responsibility
The manufacturer named in the declaration assumes legal responsibility for compliance.
4. Description of the Packaging
The packaging covered by the declaration must be sufficiently described. The description should enable authorities and downstream economic operators to understand:
- Packaging type
- Packaging materials
- Intended use
- Relevant packaging characteristics
5. Compliance and responsibility statement
The declaration must contain a clear statement that the packaging complies with the applicable PPWR requirements, for example:
“The packaging described in this declaration complies with all applicable requirements laid down in Articles 5 to 12 of Regulation (EU) 2025/40.”
Furthermore, the legal responsibility should be clearly emphasized:
“The manufacturer accepts legal responsibility for the conformity of the packaging and for the accuracy of the declaration.”
The DoC must refer to the applicable legal framework and demonstrate that the packaging complies with the PPWR requirements, in particular compliance with the relevant requirements of Articles 5-12. Not all requirements of Articles 5-12 apply to every packaging type. Manufacturers should assess the applicability based on the characteristics and intended use of the packaging concerned.
The assessment of compliance could be depicted as follows:
| PPWR Requirement | Compliance Status | References: Certificate No., test report, notified body, etc. |
|---|---|---|
| Article 5 – Requirements for substances in packaging | ||
| Article 6 – Recyclable packaging requirements | ||
| Article 7 – Minimum recycled content in plastic packaging | ||
| Article 8 – Bio-based plastic packaging | ||
| Article 9 – Compostable packaging requirements | ||
| Article 10 – Packaging minimisation requirements | ||
| Article 11 – Reusable packaging requirements | ||
| Article 12 – Packaging refill requirements |
Applicable references could be for example:
- Test reports demonstrating compliance with Article 5 heavy metal limits.
- Recyclability Assessment Report according to Article 6.
- Recycled Content Verification Certificates
- etc.
6. References to Applicable Standards
The DoC should contain references to the applicable standards used to demonstrate compliance. Depending on the packaging type, these may include standards for recyclability, environmental claims, material recovery, etc.
The DoC is not considered a standalone document and must be supported by the Technical Documentation according to Annex VII. This technical documentation should contain all evidence necessary to substantiate the compliance claims made in the declaration.
The format of providing this information may be as depicted in the table below. The standards listed below are examples of existing EN and ISO standards which may support aspects of packaging compliance. Their inclusion does not imply that they are harmonized standards under Article 36 PPWR or that their use automatically establishes compliance.
| EN / ISO Standard | Certificate No., test report No., supplier declaration, etc. |
|---|---|
| EN 13428 – Prevention by source reduction (Packaging minimization) | |
| EN 13430 – Material recycling requirements for packaging | |
| EN 13431 – Energy recovery requirements for packaging | |
| EN 13432 – Requirements for packaging recoverable through composting and biodegradation | |
| EN 13427 – Use of European standards in the field of packaging and packaging waste | |
| EN 15343 – Recycled plastics traceability and recycled content assessment | |
| ISO 18601 / ISO 18602 – Packaging and the environment; optimization of packaging systems | |
| ISO 18603 / ISO 18604 – Requirements for reuse and material recycling | |
| ISO 18606 – Organic recycling / composting of packaging |