EU PPWR Conformity Documentation

Start the file at packaging-type level. Annex VII describes internal production control as the conformity assessment procedure and requires technical documentation that makes it possible to assess conformity with the applicable PPWR requirements.

A usable file should identify the packaging, intended use, design and manufacturing information, component materials, applicable PPWR requirements, standards or specifications used, assessment methods, risk analysis, and test reports. It must also show how production controls keep manufactured packaging aligned with the approved technical documentation. Keep the file narrow enough that a reviewer can tell which packaging type the evidence supports.

Manufacturers carry the core PPWR documentation duty: before placing packaging on the market, they must carry out or arrange the conformity assessment procedure and draw up the technical documentation unless Article 15(11) applies. Where Article 15(2) applies and compliance is demonstrated, they must draw up the EU declaration of conformity.

Suppliers must provide the manufacturer with the information and documentation needed to demonstrate conformity, including technical documentation required under or pursuant to Articles 5 to 11. Article 15(12) treats the Union supplier as the manufacturer for Article 15 where a qualifying micro-enterprise has packaging or a packaged product designed or manufactured under its own name or trademark. Importers do not replace the required manufacturer file, but they must check that the required conformity assessment was carried out, the required technical documentation was drawn up, and the declaration can be kept available for market surveillance authorities.

The EU declaration of conformity is the manufacturer's signed statement, issued under its sole responsibility, that the applicable requirements in or under Articles 5 to 12 have been demonstrated. It must follow Annex VIII, contain the elements specified in Annex VII Module A, stay continuously updated, and use or be translated into the languages required by the Member State where the packaging is placed or made available.

Identify the packaging, manufacturer, object of the declaration, relevant Union legislation, standards or specifications used, and signature details. Complete the notified-body field only where another applicable Union act makes a notified body relevant; Annex VII Module A does not require one for PPWR conformity.

Treat the technical file as an approval gate for packaging release. Connect engineering records, supplier declarations, standards decisions, test reports, and label or information evidence to the specific PPWR requirements that apply. A legacy standard under Directive 94/62/EC does not automatically give a PPWR presumption of conformity; record whether the standard or common-specification reference covers the PPWR requirement and has the legal status claimed.

Where the file relies on harmonised standards, record the standard reference and the parts applied. Where the file does not rely on a harmonised standard or common specification, record the solution used to meet the applicable PPWR requirement and the evidence supporting that solution.

Build retention into the release workflow. Where Article 15(3) applies, manufacturers keep the technical documentation and declaration for 5 years after single-use packaging is placed on the market and 10 years after reusable packaging is placed on the market. Importers have matching access duties for declarations and technical documentation where those documents are required.

Authority-response procedures should be practical. On a reasoned request, manufacturers and importers must provide the conformity information, including technical documentation, in a language the authority can easily understand. The relevant documents must be available within 10 days after receipt. Distributors provide the relevant information and documents to which they have access, but Article 19 does not assign them the manufacturer's document-retention duty.