ESPR Conformity Assessment Procedures: Annex VI Explained
ESPR Annex VI defines the internal production control conformity assessment procedure — the most commonly used route for manufacturers to demonstrate that their products comply with ESPR ecodesign requirements. Understanding Annex VI is essential for any manufacturer preparing for ESPR compliance, as it defines the documentation requirements, testing obligations, and quality management procedures that must be in place before a product can carry the CE marking and be placed on the EU market.
What Is Annex VI Internal Production Control?
Internal production control is a conformity assessment procedure in which the manufacturer takes sole responsibility for demonstrating that their product complies with the applicable ESPR ecodesign requirements. Unlike Annex VII (which requires involvement of a notified body), Annex VI is a self-declaration procedure — the manufacturer designs the product to meet the requirements, tests it, documents the results, and declares conformity without third-party verification.
Annex VI is the default conformity assessment procedure for ESPR. Unless the applicable delegated act specifically requires Annex VII (third-party assessment), manufacturers may use Annex VI. The Battery Regulation uses Annex VI for most battery types, with Annex VII required only for batteries above a specified capacity threshold.
Annex VI Procedure: Step by Step
| Step | Action Required | Documentation Output |
|---|---|---|
| 1. Design | Design product to meet all applicable ecodesign performance requirements in the delegated act | Design specifications, engineering drawings |
| 2. Technical documentation | Compile technical file as specified in ESPR Article 29 and Annex VI | Technical file (see below) |
| 3. Testing | Test product against all applicable performance requirements using specified test methods | Test reports, measurement results |
| 4. DPP creation | Create Digital Product Passport containing all data fields required by Annex III and the delegated act | DPP record in compliant registry |
| 5. EU Declaration of Conformity | Draw up EU Declaration of Conformity as specified in ESPR Article 30 | Signed EU DoC document |
| 6. CE marking | Affix CE marking to product, packaging, or accompanying documents | CE mark on product |
| 7. Record keeping | Retain technical documentation for minimum 10 years after last product placed on market | Archived technical file |
Technical File Contents Under Annex VI
The technical file is the core document of the Annex VI procedure. It must contain sufficient information to demonstrate that the product meets all applicable ecodesign requirements. ESPR Annex VI specifies the minimum contents of the technical file, which includes a general description of the product and its intended use, design and manufacturing drawings, a list of harmonised standards applied, results of design calculations and examinations, test reports, a copy of the EU Declaration of Conformity, and a copy of the Digital Product Passport.
The technical file must be compiled before the product is placed on the EU market and must be updated whenever the product design changes in a way that affects compliance. The manufacturer must be able to provide the technical file to market surveillance authorities within 10 days of a request. Failure to provide the technical file on request is itself a compliance failure under ESPR Article 29(4).
When Annex VII Is Required Instead of Annex VI
The applicable delegated act specifies which conformity assessment procedure applies to each product category. Annex VII — which requires involvement of a notified body — is required when the delegated act determines that the risk of non-compliance is high enough to warrant third-party verification. This is typically the case for products with significant environmental impact, products where self-testing is technically difficult, or products where the consequences of non-compliance are severe. The Battery Regulation requires Annex VII for industrial batteries above 2 kWh — the same batteries that require a Battery Passport from 18 February 2027.
Annex VI: The Standard Conformity Assessment Procedure
ESPR Annex VI sets out the standard conformity assessment procedure for ESPR — "internal production control." This is the procedure that most manufacturers will use for most product categories. It does not require involvement of a notified body — the manufacturer conducts the conformity assessment themselves, compiles the technical documentation, draws up the EU Declaration of Conformity, and affixes the CE marking. The manufacturer is responsible for the accuracy of the conformity assessment.
Annex VI is described as "internal production control" because the key control is the manufacturer's own quality management system — the internal processes that ensure every unit of a product model meets the same specifications as the unit that was assessed for conformity. The manufacturer must have documented processes for production control, quality testing, and non-conformity management. These processes do not need to be certified (ISO 9001 certification is not required) but they must be documented and must be available to market surveillance authorities on request.
Annex VI Procedure Steps
| Step | Responsible Party | Output Document |
|---|---|---|
| 1. Product design assessment | Manufacturer | Design calculations, test plans |
| 2. Product testing | Manufacturer (or accredited test lab) | Test reports |
| 3. Technical documentation compilation | Manufacturer | Technical file (Annex VI Section 1) |
| 4. DPP data collection | Manufacturer | DPP data record |
| 5. DPP registration | Manufacturer (or DPP service provider) | DPP registered with EPREL |
| 6. EU Declaration of Conformity | Manufacturer | Signed EU DoC |
| 7. CE marking affixing | Manufacturer | CE marking on product/packaging |
| 8. Production control | Manufacturer (ongoing) | Quality records |
When Annex VI Is Sufficient
Annex VI is the default conformity assessment procedure under ESPR. The delegated act for a product category specifies whether Annex VI alone is sufficient or whether Annex VII (third-party assessment) is required. For most product categories, Annex VI will be sufficient. Annex VII is expected to be required for higher-risk products or products where self-declaration is considered insufficient — such as products with complex supply chains, products with high environmental impact claims, or products where previous market surveillance has identified systematic non-compliance.
Using Accredited Test Laboratories
Annex VI does not require manufacturers to use accredited test laboratories — they can conduct testing in-house. However, using accredited test laboratories (accredited to ISO/IEC 17025) provides greater credibility for the test results and reduces the risk of market surveillance challenges. For products where the test methods are complex or require specialised equipment, using an accredited test laboratory is strongly recommended even if it is not required by the delegated act.
Annex VI Module A: Internal Production Control
Annex VI of ESPR describes the conformity assessment procedures available to manufacturers. Module A (Internal Production Control) is the simplest procedure — the manufacturer conducts the conformity assessment themselves without involvement of a notified body. Under Module A, the manufacturer must: prepare technical documentation demonstrating that the product meets the applicable ESPR requirements, implement internal production controls to ensure that manufactured products conform to the technical documentation, draw up an EU Declaration of Conformity, and affix the CE marking. Module A is available for products where the ESPR delegated act does not require third-party involvement. For most consumer product categories, Module A will be the standard conformity assessment procedure.
Annex VI Module D1: Quality Assurance of the Production Process
Module D1 (Quality Assurance of the Production Process) requires the manufacturer to operate an approved quality management system for production, final product inspection, and testing. The quality management system must be approved by a notified body, which conducts an initial assessment and periodic surveillance audits. Module D1 is typically required for higher-risk product categories or where the delegated act specifies that third-party oversight of the production process is necessary. Manufacturers that already hold ISO 9001 certification have a significant head start on Module D1 compliance, as the ISO 9001 quality management system requirements substantially overlap with the Module D1 requirements.
Annex VI Module H: Full Quality Assurance
Module H (Full Quality Assurance) is the most comprehensive conformity assessment procedure — it covers design, production, and final inspection under a notified body-approved quality management system. Module H is typically required for the highest-risk product categories. Under Module H, the manufacturer must operate a quality management system that covers the entire product lifecycle from design through production to final inspection, and the notified body must conduct initial approval and periodic surveillance audits. The quality management system must meet the requirements of ISO 9001 as a minimum, with additional requirements specific to the ESPR delegated act for the product category. Manufacturers subject to Module H should engage with a notified body early in the product development process to ensure their quality management system will meet the requirements before the ESPR deadline.
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Register Your Digital Product Passport →Annex VI Conformity Assessment: Internal Production Control
ESPR Annex VI describes the internal production control procedure, which is the conformity assessment procedure that manufacturers can use to demonstrate compliance with ESPR requirements without involving a third-party notified body. Internal production control is the least burdensome conformity assessment procedure and is available for most product categories under ESPR, unless the relevant delegated act specifies that a more rigorous procedure is required.
Under the internal production control procedure, the manufacturer is responsible for ensuring that the product meets all applicable ESPR requirements. The manufacturer must: design and manufacture the product in accordance with the applicable delegated act; draw up the technical documentation required by Annex VII; draw up the EU declaration of conformity; affix the CE marking to the product; and keep the technical documentation and EU declaration of conformity available for inspection by market surveillance authorities for a minimum of 10 years after the last unit is placed on the market.
The internal production control procedure does not require the manufacturer to have the product tested by an independent laboratory or certified by a notified body. However, the manufacturer must be able to demonstrate, on request from a market surveillance authority, that the product meets all applicable requirements. This means that the manufacturer must have robust internal testing and quality control procedures, and must maintain detailed records of the testing and quality control activities. A manufacturer who cannot demonstrate compliance on request is in the same position as a manufacturer who has not complied — the absence of documentation is treated as evidence of non-compliance.
Frequently Asked Questions
Annex VI (internal production control) allows manufacturers to self-certify compliance without involving a notified body. Annex VII (third-party conformity assessment) requires manufacturers to have their products tested and certified by an independent notified body. The applicable delegated act specifies which procedure is required for each product category.
The internal production control procedure is available for most product categories under ESPR, unless the relevant delegated act specifies that a more rigorous procedure is required. Delegated acts for high-risk products (such as products containing hazardous substances or products with significant safety implications) may require third-party conformity assessment under Annex VII.
Under Annex VI, manufacturers must maintain technical documentation that demonstrates that the product meets all applicable ESPR requirements. This includes: product design documentation, test reports, calculation sheets, material composition data, supply chain documentation, and quality control records. The technical documentation must be available for inspection by market surveillance authorities for at least 10 years after the last unit is placed on the market.
The EU declaration of conformity is the document in which the manufacturer declares that the product meets all applicable ESPR requirements. The declaration of conformity is drawn up on the basis of the technical documentation maintained under Annex VI. The declaration of conformity must be signed by the manufacturer or their authorised representative and must include the information specified in ESPR Annex V.
If a market surveillance authority finds that a product does not comply with ESPR requirements, it can require the manufacturer to take corrective action. Corrective action may include: withdrawing the product from the market, recalling products already sold, updating the DPP data, or modifying the product design. The authority may also impose financial penalties and refer the case to the national enforcement authority for prosecution.