EU compliance
Declaration of Conformity (DoC)
An EU Declaration of Conformity is the manufacturer's formal statement, where required by the applicable Union legislation, that the product or packaging complies with the legal requirements covered by that declaration. It is supported by the applicable conformity assessment and technical documentation and is separate from EPR registration and reporting.
Overview
There is no single universal Declaration of Conformity regime for every product. The applicable Union legal act determines whether an EU Declaration of Conformity is required, which requirements it covers, its prescribed structure, language, format and retention period.
For packaging under Regulation (EU) 2025/40 on packaging and packaging waste (PPWR), Article 39 and Annex VIII establish the EU Declaration of Conformity framework. For batteries under Regulation (EU) 2023/1542 on batteries and waste batteries, Article 18 and Annex IX establish a separate declaration framework. Electrical and electronic equipment must be assessed under the Union product legislation applicable to that equipment. The WEEE regime itself concerns waste electrical and electronic equipment and should not be presented as the legal basis for a universal EEE Declaration of Conformity.
The Declaration of Conformity is a product-compliance document. It does not replace producer registration, EPR representation, producer-responsibility arrangements, records or reporting.
Who is affected
- Manufacturers responsible under Union legislation requiring an EU Declaration of Conformity
- Companies placing products on the market under their own name or trademark where the applicable legislation gives them manufacturer obligations
- Authorised representatives where the applicable legislation and written mandate permit specified DoC-related tasks
- Importers that must verify that the required conformity assessment and documentation exist
- Distributors where the applicable legislation assigns verification or due-care duties
- The economic operator responsible for the Declaration of Conformity is determined by the applicable product legislation and must not be confused with the producer responsible for national EPR.
Key obligations
- Identify every applicable Union legal act that requires an EU Declaration of Conformity for the product or packaging.
- Complete the conformity-assessment procedure required by the applicable legislation and establish the supporting technical documentation.
- Use the declaration structure and content prescribed by the applicable legal act and identify the product or packaging so that it can be traced.
- Reference the applicable Union legislation and the relevant harmonised standards, common specifications or other technical specifications where required.
- Keep the declaration up to date and maintain it, together with the supporting technical documentation, for the retention period required by the applicable legislation.
- Provide or translate the declaration into the language or languages and format required for the relevant Member State and legal regime.
Documentation and data requirements
The Declaration of Conformity must be supported by the technical documentation required under the applicable legislation. The declaration and the technical file are related but separate documents.
The technical file contains the evidence used to demonstrate conformity — for example the applicable legal requirements, product or packaging description, design and material information, standards or technical specifications used, calculations, assessments, test reports and other supporting evidence where relevant.
The declaration summarises the legal conformity statement and references the legislation and technical basis on which that statement is made. The required content of both documents depends on the applicable Union legal act.
Relationship with conformity assessment
The Declaration of Conformity is the result of the applicable conformity process, not a substitute for it. The responsible manufacturer first identifies the applicable legal requirements, completes or arranges the required conformity assessment and establishes the technical documentation needed to demonstrate compliance.
The declaration is drawn up once the applicable conformity requirements have been demonstrated. A declaration therefore cannot reliably be prepared from product identification data alone. Its legal references and statements must be supported by the underlying technical file.
PPWR Declaration of Conformity
For packaging under PPWR, Article 39 requires the EU Declaration of Conformity to state that compliance with the requirements laid down in or pursuant to Articles 5 to 12 has been demonstrated. The declaration follows the model structure in Annex VIII and includes, among other elements, identification of the packaging, the manufacturer and where applicable its authorised representative, the object of the declaration, the relevant Union legislation, references to applicable harmonised standards, common specifications or other technical specifications, any relevant notified-body information where applicable, and the signature information.
The declaration must be kept up to date. Under the PPWR framework, the manufacturer keeps the declaration and technical documentation for five years for single-use packaging and ten years for reusable packaging.
Battery Declaration of Conformity
Regulation (EU) 2023/1542 has its own EU Declaration of Conformity framework for batteries. Article 18 requires the declaration to follow Annex IX, remain up to date and identify the battery for which it is issued. The Battery Regulation uses its own conformity-assessment procedures and declaration requirements.
Its EU Declaration of Conformity must therefore not be treated as the PPWR declaration simply because a battery may be supplied inside packaged equipment. Where the battery or another product is subject to more than one applicable Union act requiring an EU Declaration of Conformity, the applicable rules for combining or referencing those legal acts must be followed.
Multiple Union acts
A product, packaging or battery may fall under more than one Union act requiring an EU Declaration of Conformity. Where the applicable legislation permits or requires a single EU Declaration of Conformity covering several Union acts, the declaration must identify those acts and their publication references.
A combined declaration does not remove the need to demonstrate compliance separately with the requirements of each applicable act.
Language and format
Language and format requirements are set by the applicable legal act. Under PPWR, the declaration must be drawn up in or translated into one or more languages required by the Member State in which the packaging is placed or made available on the market.
Under Regulation (EU) 2023/1542, the battery declaration must likewise be translated into the language or languages required by the relevant Member State; the Regulation also requires it to be drawn up electronically and provided in paper form where requested.
Authorised representative
Product-compliance authorised representation and EPR authorised representation are separate legal roles. An authorised representative may perform only those conformity-related tasks that the applicable Union legislation allows and that are covered by a valid written mandate.
The manufacturer's legal responsibility is not transferred merely because an authorised representative performs an administrative or documentation task. An appointment as an authorised representative for EPR does not by itself authorise that entity to prepare, sign or maintain an EU Declaration of Conformity under product legislation.
Manufacturer responsibility
The Declaration of Conformity is issued under the responsibility assigned to the manufacturer by the applicable Union legislation. For PPWR, Article 39 expressly states that by drawing up the EU Declaration of Conformity the manufacturer assumes responsibility for the compliance of the packaging with the Regulation.
The same principle applies under Article 18 of Regulation (EU) 2023/1542 for batteries.
How we assist
- Identifying which Union legal acts require a Declaration of Conformity
- Checking which declaration model or annex applies
- Mapping the declaration to the applicable conformity assessment and technical file
- Reviewing the available evidence and legal references for apparent completeness
- Structuring a draft declaration using the applicable legal model
- Identifying missing technical evidence, testing or specialist input
- Coordinating language versions and document-control requirements
- Reviewing whether multiple applicable Union acts can or should be reflected in a combined declaration
EPR Entry is the commercial coordination platform. Declaration-of-Conformity support is delivered through the legal service provider identified for the relevant engagement.
The manufacturer or other responsible economic operator retains the legal responsibility assigned by the applicable Union legislation. Where specialist laboratory testing, conformity assessment or formal legal interpretation is required, that work is identified separately.
Frequently asked questions
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