Declaration of Conformity (DoC) Requirements For Importers & Amazon Sellers

A Declaration of Conformity (DoC) is mandatory for all products covered by one or more ‘CE marking’ directives. In this guide for importers and Amazon sellers, we explain how to create a DoC, associated costs, relevant products, and much more.

DoC Sample Texts

Further, this guide also includes Declaration of Conformity sample texts for the following:

• Low Voltage Directive 2014/35/EU
• EMC Directive 2014/30/EU
• Radio Equipment Directive 2014/53/EU
• RoHS Directive 2011/65/EU
• Toy Safety Directive 2009/48/EC
• Personal Protective Regulation (EU) 2016/425
• Ecodesign Directive 2009/125/EC

What is a Declaration of Conformity (DoC)?

The Declaration of Conformity is a self-issued document ‘declaring’ that a certain product is compliant with certain product directives and standards. This information is normally included:

• Product identification/SKU
• Product features
• Name and address of the manufacturer/importer
• List of EN standards and/or EU directives
• Location
• Responsible individual

The exact information can be found in the relevant directives or regulations. That said, the DoC must be supported by a test report and technical file.

Further, the DoC is normally issued on a ‘per product’ basis. As such, you need to create one DoC per product. The DoC must also be updated in case additional regulations or standards are added in the future.

Which products require a Declaration of Conformity?

The Declaration of Conformity is mandatory for all products which must be CE marked. As such, the Doc is part of the CE marking process.

Here are some examples of products for which a DoC is required:

• Electronics
• Gloves
• Helmets
• Sunglasses
• Bicycles
• Machinery
• Toys
• Medical devices

Examples of CE Directives:

• RoHS Directive
• Low Voltage Directive
• EMC Directive
• Radio Equipment Directive
• Toy Safety Directive
• Personal Protective Equipment Directive
• Medical Devices Directive

How do I get a Declaration of Conformity?

Here are a few different ways to obtain a Declaration of Conformity:

Create it yourself: Information about what to include in your DoC is available on the official EU website – as long as you know which directives and regulations apply to your product. That’s often the hard part. You can also contact consumer product safety authorities in EU countries and ask them for guidance on applicable regulations and what information you’ll need to include in your DoC.

• Step 1: Confirm mandatory regulations
• Step 2: Confirm required DoC information
• Step 3: Create your DoC
• Step 4: Print and sign the DoC

Consultants: INSTRKTIV and other consulting firms can help you create a DoC from scratch. All you’ll need to do is to sign and you’re done. Most consultants charge from a few hundred EURs and up.

Online Services: Product IP and CE-check.eu provides online platforms, helping importers and manufacturers create DoCs with relative ease. You can also buy DoC templates from various websites.

Are importers responsible for issuing the DoC?

The DoC can either be issued by a manufacturer or an importer. However, in most cases, the importer is considered as the manufacturer in the following scenarios:

• You import custom-designed products from a manufacturer outside the EU
• You import private label products from a manufacturer outside the EU

Can I get a Declaration of Conformity from my supplier?

Most manufacturers in China, and other countries outside the EU, don’t have the experience or expertise to issue a correct Declaration of Conformity. In short, they simply don’t know how to create a DoC.

Importers and Amazon sellers should not rely on their suppliers to issue a DoC. Also, keep in mind that a Declaration of Conformity is not the only document you need when importing CE marked products to the EU.

Do I need a Declaration of Conformity for selling on Amazon?

Amazon requires that products sold on its platform comply with the national regulations and standards. As such, sellers of electronics, toys, sunglasses, and other ‘CE products’ must provide a DoC.

Amazon often requests additional information:

• Declaration of Conformity
• Test report
• CE mark product images
• Invoice

Further, Amazon doesn’t accept any DoC at face value. Your Doc is likely to be rejected if it doesn’t include the required information.

How much does it cost to get a Declaration of Conformity?

It doesn’t cost anything to self-issue a Declaration of Conformity. That said, costs arise if you intend to get help from a consultant, buy a template, or use a software tool.

Here are a few DoC cost examples:

• Consultant: 500 EUR
• Online Service: 100 – 300 EUR
• Template: 50 – 150 EUR

What’s the difference between a test report and a DoC?

A DoC is essentially a ‘compliance statement’. The DoC itself doesn’t prove that the product is compliant with the requirements outlined in applicable directives and regulations.

Test reports, on the other hand, list applicable standards, tests, procedures, and results – which in turn supports the statements on the DoC.

That said, a test report is not a replacement or substitute for a DoC.

Do I need to send the Declaration of Conformity to the customs authorities?

The DoC is generally not part of the customs documentation. That said, the customs authorities can request a DoC upon entry in an EU member state.

What can happen if I don’t have a Declaration of Conformity?

Consumer product safety authorities in EU countries can request a Declaration of Conformity at any time. They may contact you weeks or even months after you’ve started selling a product.

Failing to provide a Declaration of Conformity often results in fines and a sales ban – meaning that you cannot continue selling your product.

As mentioned, Amazon may also suspend your product listings.

In short, make sure you have your Declaration of Conformity in place before you start importing and selling CE products in the EU.

Is the DoC content the same for all CE directives?

The information required to be included in a DoC is similar, but not exactly the same in the various “CE directives and regulations”. Here are some notable differences:

• Some directives/regulations require product photos to be included (while it’s optional for others)
• Some directives/regulations require notified body information
• Different terminology (e.g. product/equipment description)

How do I find the information required in a DoC?

Each CE directive and regulation includes a list of DoC contents to be included. These are freely available on the official EU website.

This list specifies under which part (annex) you can find the DoC contents for various directives and regulations:

• Low Voltage Directive 2014/35/EU: ANNEX IV
• EMC Directive 2014/30/EU: ANNEX IV
• Radio Equipment Directive 2014/53/EU: ANNEX VI
• RoHS Directive 2011/65/EU: ANNEX VI
• Toy Safety Directive 2009/48/EC: ANNEX III<
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• Personal Protective Regulation (EU) 2016/425: ANNEX IX
• Ecodesign Directive 2009/125/EC: ANNEX VI

Declaration of Conformity Sample Texts

The following sample texts can be found on ec.europa.eu. We recommend that you only refer to the source texts as the information below may be outdated.

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Low Voltage Directive 2014/35/EU DoC

EU DECLARATION OF CONFORMITY (No XXXX) (1)

1. Product model/product (product, type, batch or serial number):

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer.

4. Object of the declaration (identification of electrical equipment allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the electrical equipment):

5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:

6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:

7. Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

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EMC Directive 2014/30/EU DoC

EU declaration of conformity (No Xxxx) (1)

1. Apparatus model/Product (product, type, batch or serial number):

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer.

4. Object of the declaration (identification of apparatus allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the apparatus):

5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:

6. References to the relevant harmonised standards used, including the date of the standard, or references to the other technical specifications, including the date of the specification, in relation to which conformity is declared:

7. Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate:

8.Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

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Radio Equipment Directive 2014/53/EU DoC

EU DECLARATION OF CONFORMITY (No XXX) (1)

1. Radio equipment (product, type, batch or serial number):

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer.

4. Object of the declaration (identification of the radio equipment allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the radio equipment):

5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:

Directive 2014/53/EU
Other Union harmonisation legislation where applicable

6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared. References must be listed with their identification number and version and, where applicable, date of issue:

7. Where applicable, the notified body … (name, number) … performed … (description of intervention) … and issued the EU-type examination certificate: …

8. Where applicable, description of accessories and components, including software, which allow the radio equipment to operate as intended and covered by the EU declaration of conformity:

9. Additional information:

Signed for and on behalf of: …

(place and date of issue):

(name, function) (signature):

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RoHS Directive 2011/65/EU Doc

EU DECLARATION OF CONFORMITY

1. No … (unique identification of the EEE):

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):

4. Object of the declaration (identification of EEE allowing traceability. It may include a photograph, where appropriate):

5. The object of the declaration described above is in conformity with Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1):

6. Where applicable, references to the relevant harmonised standards used or references to the technical specifications in relation to which conformity is declared:

7.Additional information:

Signed for and on behalf of: …

(place and date of issue):

(name, function) (signature):

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Toy Safety Directive 2009/48/EC DoC

EC DECLARATION OF CONFORMITY

1. No … (unique identification of the toy(s))

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer:

4. Object of the declaration (identification of toy allowing traceability). It shall include a colour image of sufficient clarity to enable the identification of the toy.

5. The object of the declaration described in point 4 is in conformity with the relevant Community harmonisation legislation:

6. References to the relevant harmonised standards used, or references to the specifications in relation to which conformity is declared:

7. Where applicable: the notified body … (name, number) … performed … (description of intervention) … and issued the certificate:

8. Additional information:

Signed for and on behalf of:

(place and date of issue)

(name, function)(signature)

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Personal Protective Regulation (EU) 2016/425 DoC

EU DECLARATION OF CONFORMITY No … (1)

1. PPE (product, type, batch or serial number):

2. Name and address of the manufacturer and, where applicable, his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer:

4. Object of the declaration (identification of PPE allowing traceability; where necessary for the identification of the PPE, a colour image of sufficient clarity may be included):

5. The object of the declaration described in point 4 is in conformity with the relevant Union harmonisation legislation: …

6. References to the relevant harmonised standards used, including the date of the standard, or references to the other technical specifications, including the date of the specification, in relation to which conformity is declared:

7. Where applicable, the notified body … (name, number) … performed the EU type-examination (Module B) and issued the EU type-examination certificate … (reference to that certificate).

8. Where applicable, the PPE is subject to the conformity assessment procedure … (either conformity to type based on internal production control plus supervised product checks at random intervals (Module C2) or conformity to type based on quality assurance of the production process (Module D)) … under surveillance of the notified body … (name, number).

9.Additional information:

Signed for and on behalf of: …

(place and date of issue):

(name, function) (signature):

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Ecodesign Directive 2009/125/EC DoC

EC declaration of conformity

(referred to in Article 5(3))

The EC declaration of conformity must contain the following elements:

1. the name and address of the manufacturer or of its authorised representative;

2. a description of the model sufficient for its unambiguous identification;

3. where appropriate, the references of the harmonised standards applied;

4. where appropriate, the other technical standards and specifications used;

5. where appropriate, the reference to other Community legislation providing for the affixing of the CE mark that is applied; and

6. the identification and signature of the person empowered to bind the manufacturer or its authorised representative.