A CE declaration, officially the EU Declaration of Conformity (DoC), is the manufacturer’s statement that a product meets the applicable EU requirements. It is needed when the legislation covering your product requires it, including products subject to CE marking. This requirement does not apply to every product and does not depend on selling through bol.com or Amazon. This guide explains when the declaration is needed and what information it must contain.
Check the requirements for your product in the official EU guidance on CE marking. It also explains when a declaration of conformity and an independent assessment are needed.
What is a CE declaration exactly?
The CE declaration is a legally binding document with which the manufacturer or importer formally declares that a product meets the essential requirements of all applicable EU directives and regulations. It's not a certificate issued by an external body - it's a self-declaration that the responsible market player sets up and signs themselves.
The CE declaration, together with the technical dossier and the CE marking on the product, forms the three pillars of European product conformity. Without this declaration, the CE marking on your product is invalid. The declaration must be available at all times for market surveillance authorities, such as the NVWA in the Netherlands or customs when importing from outside the EU.
The three pillars of CE conformity
To legally bring a product to the European market, you need three elements that are inextricably linked:
- Technical dossier - all technical documentation, test reports, and risk analyses
- CE declaration (Declaration of Conformity) - the formal document that declares conformity
- CE marking - the physical CE logo on the product or packaging
Difference between CE declaration, CE certificate, and CE marking
There's a lot of confusion about the different terms surrounding CE. Many sellers and even some manufacturers use these terms interchangeably, while they fundamentally mean different things. Below, we'll outline the main differences:
| Term | What is it? | Who sets it up? | Required? |
|---|---|---|---|
| CE declaration (DoC) | Legally binding document that declares conformity to EU directives | Manufacturer or EU-authorized representative | Yes, always required for CE marking |
| CE certificate | Informal term - does not officially exist; often refers to a test report from a notified body | Test laboratory or notified body | Only for high-risk products (notified body required) |
| CE marking | The physical CE logo on the product or packaging | Manufacturer applies it | Yes, must be visible on the product or packaging |
| Technical dossier | Complete technical documentation including test reports, risk analysis, and product descriptions | Manufacturer | Yes, must be kept for 10 years |
| Test report (EMC/LVD) | Results of specific product tests according to harmonized standards | Test laboratory | Part of the technical dossier |
A common mistake is that sellers consider a test report or a statement from the Chinese manufacturer as a valid CE declaration. A test report is only part of the technical file, while the declaration of conformity is a separate, formal document that must meet specific requirements. Use tools like the Product Database to investigate which products in your category require a CE marking.
When do you need a CE declaration?
Not all products require a CE marking and therefore not all of them require a CE declaration. The obligation depends on which EU directives or regulations apply to your product. Below you'll find an overview of the most important product categories that require a CE declaration:
| EU directive/regulation | Product category | Examples | Notified body required? |
|---|---|---|---|
| Low Voltage Directive (2014/35/EU) | Electrical equipment (50-1000V AC) | Chargers, lamps, kitchen appliances | Mostly not |
| EMC Directive (2014/30/EU) | Electromagnetic compatibility | Electronics, LED lighting, motors | Mostly not |
| Machinery Directive (2006/42/EG) | Machines and safety components | Tools, pumps, conveyor belts | For hazardous machines, yes |
| Toy Directive (2009/48/EG) | Toys for children <14 years | Plush toys, building sets, puzzles | For chemical risks, yes |
| PPE Regulation (EU 2016/425) | Personal protective equipment | Safety helmets, gloves, hearing protection | For Category II and III, yes |
| RED Directive (2014/53/EU) | Radio equipment | Bluetooth speakers, WiFi routers, walkie-talkies | For certain frequencies, yes |
| Construction Products Regulation (EU 305/2011) | Construction products | Doors, windows, insulation materials | Mostly yes (DoP instead of DoC) |
| Medical Devices (MDR 2017/745) | Medical equipment | Thermometers, blood pressure meters, bandages | For Class Is and higher, yes |
If you import products from China or another country outside the EU, you as the importer are legally responsible for CE compliance. This means you must check if the manufacturer has a valid technical file and that you draw up or check a CE declaration yourself. Check out our guide to the CE marking for more background information.
What should be included in a CE declaration?
The content of the CE declaration is legally defined and varies slightly per directive, but always includes at least the following elements:
- Manufacturer's name and address - and, if applicable, the authorized representative in the EU
- Product identification - product name, type, serial number or batch number by which the product can be uniquely identified
- Reference to applicable EU directives - all directives with which the product must comply, including the full number and name
- Reference to harmonized standards - the specific EN standards applied (e.g. EN 62368-1, EN 55032)
- Name and number of the notified body - if applicable in the conformity assessment
- Date and place of issue - when and where the declaration was drawn up
- Name, function and signature - of the person signing on behalf of the manufacturer or importer
- Declaration of conformity - the formal text stating that the product complies with the above-mentioned directives
The declaration must be drawn up in the language or languages of the EU country where the product is sold. For sale in the Netherlands, a Dutch version must be available at least.
Creating a CE declaration: step by step
Creating a valid CE declaration requires a systematic approach. Below, we describe the entire process in six steps:
Step 1: Determine the applicable directives
Identify which EU directives and regulations apply to your product. For example, a Bluetooth speaker falls under both the RED directive (radio equipment) and the Low Voltage Directive and the EMC directive. All applicable directives must be mentioned in the CE declaration.
Step 2: Identify the harmonized standards
Find out which EN standards (European Norms) have been published by the European Commission as harmonized standards under those directives. These standards provide a presumption of conformity - if your product complies with the standard, it is assumed to comply with the directive.
Step 3: Conduct tests and assessments
Have your product tested according to the applicable standards. For many products, you can do this at any accredited test laboratory. For products with a higher risk (such as certain toys or MDDs category III), you must involve a notified body.
Step 4: Compile the technical file
Collect all documentation in a technical file: product description, drawings, test reports, risk analysis, user manual, and production process controls. This file must be kept for at least 10 years after the last product has been placed on the market.
Step 5: Create the CE declaration
Create the formal document with all mandatory elements (see above). Ensure that the declaration is signed by an authorized person within your organization. The declaration must be available in the language of each EU country where you sell.
Step 6: Affix the CE marking
After signing the CE declaration, you may affix the CE marking to the product. The logo must be at least 5 mm high, visible, and indelible. If a notified body was involved, the four-digit identification number must be placed next to the CE logo.
Common mistakes in the CE declaration
Experience shows that sellers and importers regularly make the same mistakes when creating or checking a CE declaration. Below are the five most common pitfalls:
- Trusting a Chinese "CE certificate" - Chinese manufacturers often provide a document they call a CE certificate, but it's actually not a valid CE declaration. Always check if the document contains all required elements
- Outdated guidelines mentioned - EU guidelines are regularly updated. A CE declaration referencing withdrawn guidelines is invalid. Always check if the mentioned guideline numbers are up-to-date
- No notified body involved when required - for certain product categories (such as PBM's category III or toys with chemical risks), a notified body is mandatory. Without their involvement, your CE declaration is invalid
- Declaration not available in the correct language - the CE declaration must be available in the official language of the country where the product is sold. For the Netherlands, that's Dutch
- Missing or incorrect product identification - the product must be uniquely identifiable via type, batch, or serial number. A generic product description without specific identification is insufficient
CE declaration and selling on bol.com
If you sell products on bol.com that fall under the CE regulations, you must be able to demonstrate that your products comply. Bol.com may request documentation, and the NVWA conducts random checks on products sold through online marketplaces. The consequences of non-compliance can be severe:
- Removal of your product offer by bol.com
- Fines from the NVWA up to €900,000 per violation
- Mandatory product recall
- Blocking of your sales account
- Liability in case of injury caused by a non-compliant product
So, always make sure you have a valid CE declaration and the accompanying technical dossier available before offering a product. Use the Product Tracker to analyze competing products and the Listing Generator AI to optimize product pages with the correct compliance information.
Documentation that bol.com can request
Bol.com and market surveillance authorities may request the following documents from you:
- The CE declaration (EU conformity declaration)
- Test reports from an accredited laboratory
- The technical dossier (or relevant parts thereof)
- Proof of involvement of a notified body (if required)
- Product photos with visible CE marking
Costs of a CE declaration
Creating the CE declaration itself is free - it's a document you can make yourself as a manufacturer or importer. However, the costs are in the preliminary process: testing your product and compiling the technical dossier. The total costs depend on the product category and complexity:
| Cost Category | Indication | Explanation |
|---|---|---|
| EMC + LVD testing | €500 – €3.000 | Standard for electronic products |
| Toy testing (EN 71) | €800 – €5.000 | Depends on materials and age group |
| Notified body assessment | €2.000 – €15.000 | Only for products that require it |
| Technical file compilation | €500 – €5.000 | Can be done internally or by a consultant |
| Risk analysis | €300 – €2.000 | Mandatory part of the technical file |
For simple electronic products, total costs often range from €1.000 to €5.000. For more complex products or when a notified body is required, costs can rise to €10.000 or more. Use the Winstcalculator to calculate whether your product margin can bear these costs, and the Sales Dashboard to monitor your sales performance.
Keeping and making the CE declaration available
The CE declaration and the technical file must be kept for at least 10 years after the date the last product was placed on the market. This is a legal requirement that applies to both manufacturers and importers. Practical tips for keeping them:
- Save the declaration digitally in a secure system with backups
- Also keep the original, signed paper version
- Maintain a register of all products for which you have a CE declaration
- Update the declaration when guidelines change or when you modify the product
- Ensure the declaration is readily available - market surveillance authorities expect it within a few days
Frequently asked questions about the CE declaration
Is a CE declaration the same as a CE certificate?
No. A CE certificate does not officially exist. The term is often confused with the CE declaration (declaration of conformity) or with a test report from a notified body. The CE declaration is the formal, legally binding document that declares conformity.
Who is responsible for the CE declaration?
The manufacturer is primarily responsible. If you import products from outside the EU and the manufacturer does not have an authorized representative in the EU, the responsibility shifts to you as the importer.
Can I use a CE declaration from my Chinese supplier?
Only if the Chinese manufacturer has appointed an authorized representative in the EU who co-signs the declaration. Without an EU-authorized representative, you as the importer are responsible and must draw up the declaration in your own name after verifying the technical file.
How long is a CE declaration valid?
A CE declaration does not have an expiration date, but it becomes invalid when the applicable directives change, the product is modified, or the harmonized standards are updated. Therefore, check regularly whether your declaration is still up-to-date.
What if my product does not need a CE marking?
If your product does not fall under one of the CE directives, you do not need a CE declaration and you are not allowed to affix a CE marking. Affixing a CE marking incorrectly is punishable. Check our guide on the CE marking to determine if your product is subject to CE marking requirements.
Do I need to send the CE declaration to customers?
You're not required to include the declaration with every order, but you must be able to provide it upon request - to both customers and market surveillance authorities. For certain product categories, such as personal protective equipment, the declaration must be included with the product.