EU compliance
Technical Documentation
Technical documentation is the evidence file used to demonstrate conformity with the requirements of the applicable Union product legislation. Its required content, assessment method and retention period depend on the legal act, product and conformity procedure concerned.
Overview
Technical documentation supports the conformity assessment required by the applicable Union legislation. It records which legal requirements apply, how conformity has been assessed and which technical evidence supports the conclusion.
The required structure is legislation-specific. Regulation (EU) 2025/40 on packaging and packaging waste (PPWR) establishes technical-documentation requirements for packaging through Article 38 and Annex VII. Regulation (EU) 2023/1542 on batteries and waste batteries uses its own conformity-assessment and technical-documentation framework under Article 17 and Annex VIII. For electrical and electronic equipment, the relevant technical-documentation duties arise from the Union product legislation applicable to the particular equipment. WEEE itself must not be presented as creating one universal technical-documentation file for all EEE.
Technical documentation is a product-conformity file. It is separate from national EPR registration, producer-responsibility arrangements, market-volume records and waste-reporting documentation.
Who is affected
- Manufacturers responsible for conformity under applicable Union legislation
- Companies treated as manufacturers because they place products or packaging on the market under their own name or trademark where the applicable legislation provides this
- Authorised representatives where permitted tasks are covered by a written mandate
- Importers that must verify that the required technical documentation has been established and can be made available where the applicable legislation requires this
- Supply-chain parties that provide specifications, declarations, test results or other evidence needed for the file
- The legal responsibility for establishing and maintaining technical documentation is determined by the applicable Union legislation. Providing technical data to the manufacturer does not by itself transfer that responsibility.
Key obligations
- Identify the Union legislation and specific legal requirements that apply to the product, packaging or battery.
- Determine the applicable conformity-assessment procedure and the technical-documentation requirements attached to that procedure.
- Establish a controlled technical file containing the product or packaging identification, applicable requirements and the evidence used to demonstrate conformity.
- Document the standards, common specifications, technical specifications, calculations, assessments, test evidence and other technical methods used where relevant.
- Maintain the file so that material design, specification, supplier, production or regulatory changes that may affect conformity are reflected.
- Keep the documentation available for the retention period and authority-access requirements established by the applicable Union legislation.
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.
Evidence structure
A technical file should be structured around the legal requirements that must be demonstrated rather than assembled as an undifferentiated collection of supplier documents. Depending on the applicable legislation and conformity procedure, relevant evidence can include:
- identification and general description of the product, packaging or battery and its intended use - design information, drawings, component or material specifications - applicable legal requirements - harmonised standards, common specifications or other technical specifications used - explanations of the technical solutions adopted where standards or specifications are not used or do not fully cover the requirement - material-composition information - supplier declarations and supporting supply-chain data - calculations and technical assessments - test reports - labelling and marking specimens - conformity-assessment records - change-control and version information
Not every evidence type is required for every product. The required file is determined by the applicable legal act and the requirements being demonstrated.
PPWR technical documentation
For packaging, PPWR Article 38 and Annex VII use Module A — internal production control. The manufacturer establishes technical documentation that must make it possible to assess the packaging's conformity with the applicable requirements and must include an adequate analysis and assessment of the risks of non-conformity.
Annex VII requires the file, where applicable, to cover the packaging description and intended use, conceptual design and manufacturing information, component materials, explanations needed to understand the design, the harmonised standards, common specifications or other technical specifications used, the solutions adopted where those specifications are not fully used, relevant assessments and test reports.
The PPWR file must also support the specific requirements being demonstrated. For example, the Regulation expressly links technical documentation to assessments concerning recyclability, packaging minimisation and reuse where those provisions apply.
PPWR retention
Under PPWR, the manufacturer keeps the technical documentation and EU Declaration of Conformity for five years after single-use packaging is placed on the market and for ten years after reusable packaging is placed on the market. These PPWR periods must not be applied automatically to technical documentation governed by other Union legislation.
Battery technical documentation
Regulation (EU) 2023/1542 uses separate conformity-assessment procedures under Article 17 and Annex VIII. The applicable module depends on the battery requirements and conformity route concerned. The technical documentation must make it possible to assess the battery's conformity with the relevant requirements and, where applicable, includes the battery description and intended use, design and manufacturing information, component and circuit information, labelling specimen, harmonised standards or common specifications applied, other technical specifications, technical solutions and supporting assessment or test evidence.
The exact evidence set therefore depends on the battery category, the requirements being assessed and the applicable conformity-assessment procedure.
Battery retention
For batteries, the manufacturer must keep the applicable technical documentation and EU Declaration of Conformity available to national authorities for ten years after the battery has been placed on the market or put into service. This retention period belongs to the Battery Regulation and must not be presented as a universal EU technical-documentation period.
EEE / product-legislation distinction
Electrical and electronic equipment can be subject to several different Union product-compliance regimes depending on the equipment and its characteristics. Technical documentation must therefore be mapped to the legislation actually applicable to the product.
The WEEE regime addresses waste electrical and electronic equipment and EPR-related obligations; it should not be used as the legal basis for a generic EEE conformity file or Declaration of Conformity.
Relationship with the Declaration of Conformity
Technical documentation and the EU Declaration of Conformity are related but separate. The technical file contains the detailed evidence supporting the conformity assessment. Once the applicable conformity requirements have been demonstrated, the responsible manufacturer draws up the Declaration of Conformity where the governing legislation requires one.
The declaration therefore should be traceable to the underlying technical file, while the technical file should support the legal claims made in the declaration.
Relationship with EPR data
Some source data may support both product conformity and EPR administration, but the legal purposes are different. Material-composition or product-master data may, for example, be relevant to a technical conformity file and also to EPR reporting.
This does not make the technical documentation an EPR report, nor does an EPR report demonstrate product conformity. The two data structures should be coordinated where useful but maintained according to their respective legal purposes.
Change control
A technical file is not a one-time archive if the product or packaging changes. Where design, materials, suppliers, manufacturing methods, applicable standards or other relevant specifications change, the responsible economic operator must assess whether the conformity evidence and documentation need to be updated.
Document version, supporting evidence and the basis of the conformity conclusion should therefore remain traceable.
Client / manufacturer responsibility
The manufacturer or other responsible economic operator retains the responsibility assigned by the applicable Union legislation for the technical documentation and conformity of the product. The reliability of the technical file also depends on complete and accurate product, design, material, supplier and test information. Documentation-support services do not transfer responsibility for the underlying technical data.
How we assist
- Identifying the applicable technical-documentation requirements
- Defining a legal-requirement-to-evidence matrix
- Structuring the technical file
- Mapping existing specifications, supplier declarations, assessments and test evidence
- Identifying apparent evidence and documentation gaps
- Coordinating requests for missing supplier data
- Identifying where external testing or specialist technical assessment may be required
- Establishing document-control and version-management logic
- Mapping the technical file to the applicable Declaration of Conformity
- Coordinating relevant source data with separate EPR compliance workflows
EPR Entry is the commercial coordination platform. Technical-documentation support is delivered through the legal service provider identified for the relevant engagement.
Where laboratory testing, specialised engineering assessment, notified-body involvement or formal legal interpretation is required, that work is identified separately.
Frequently asked questions
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