Declaration of Conformity (DoC) Requirements in the EU: A Complete Guide

Creating a Declaration of Conformity is mandatory when manufacturing toys, electronics, machinery, PPE, medical devices, and many other products for the EU market. This guide addresses many of the most common questions about Declaration of Conformity requirements in the European Union.

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What is an EU Declaration of Conformity?

A Declaration of Conformity is a self-issued document providing detailed information about a product and which EU regulations, directives, and standards this product complies with.

A Declaration of Conformity must be created for products that are subject to CE marking requirements.

Is the Declaration of Conformity mandatory in the EU?

Creating a Declaration of Conformity is mandatory if your product is subject to one or more EU regulations and directives that, in turn, require a Declaration of Conformity. Whether this is the case depends on whether your product fits within the scope of one or more CE marking regulations or directives.

Which products require a Declaration of Conformity in the EU?

Here are some examples of products that require a Declaration of Conformity:

• Toys
• Electronics
• E-bikes
• Batteries
• Sunglasses
• Protective gloves
• Protective clothes
• Protective shoes
• Helmets
• Other PPE
• Medical devices
• Gas Appliances
• Measuring Instruments

Which EU regulations and directives require a Declaration of Conformity?

The table below lists various EU regulations and directives that require a Declaration of Conformity. We also specify which Annex contains the Declaration of Conformity model structure for each of these.

Do we need to create one EU Declaration of Conformity for each product?

Yes, you are generally required to create a single Declaration of Conformity for each product model you manufacture for the EU market. However, there are instances where you can include more than one version of a variation of the same product in a single Declaration of Conformity.

This includes, for example, different colours and other variations.

Can multiple products be included in the EU Declaration of Conformity?

Each Declaration of Conformity must include information about the applied regulations and directives, and standards. As such, including products subject to different regulations, directives or standards in a single Declaration of Conformity is not practical.

How do I create an EU Declaration of Conformity?

The following guides explain how the creation of Declaration of Conformity documents works in practice:

How to create an EU Declaration of Conformity for electronics

How to create an EU Declaration of Conformity for toys

Note that the process is similar for other product categories.

Who creates the EU Declaration of Conformity?

The Declaration of Conformity must generally be created by the manufacturer. Keep in mind that a manufacturer doesn’t necessarily mean the factory operator, but can include the following entities:

1. A company that operates the manufacturing facility

2. A company using contract manufacturers to produce products based on their design

3. A company using contract manufacturers to produce products with their branding

As such, a company ordering custom-designed or private label products from a factory in China is likely the manufacturer, who is therefore responsible for creating the Declaration of Conformity.

Likewise, a Chinese or American manufacturer who wants to sell in the EU should also create a DoC, as this is a precondition for EU importers to be able to buy their products.

Can EU importers create a Declaration of Conformity?

No, the responsibility to issue a Declaration of Conformity normally falls on the manufacturer, not the importer. Note that an importer can, as explained above, also assume the role of a manufacturer if they order products:

a. Based on their design

b. With their branding

Can non-EU companies issue a Declaration of Conformity?

Yes, if they are the manufacturer of the product. As such, manufacturers in the United States, the United Kingdom, China, and other non-EU countries can issue a Declaration of Conformity.

What information should be included in an EU Declaration of Conformity?

The exact information requirements depend on the applicable EU regulations and directives. This is due to the DoC model structure differing to some extent.

That said, this information must normally be included:

• Product model name
• Manufacturer information
• Product traceability information
• Compliance statement
• Applicable EU regulations and directives
• Applicable product standards
• Notified body information
• Name and signature

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

Lacking a Declaration of Conformity can result in fines or even recalls. I have also dealt with cases when the customs authorities have denied entry to full containers on the basis of the importer missing a DoC – resulting in either destruction of the products or a return shipment to the factory.

It is therefore crucial that you have a compliant Declaration of Conformity in place when you introduce a product to the EU market.

When do we need a Declaration of Conformity?

You need a Declaration of Conformity before you place a product on the EU market. Placing a product on the EU market generally refers to the following events:

1. You import finished goods into the EU

2. You manufacture finished goods and start selling these products within the EU

Generally speaking, having a Declaration of Conformity in place when your product is made available for sale is mandatory. You cannot skip this step and issue a Declaration of Conformity upon request at a later stage.

What should we do with the Declaration of Conformity?

Once created, you need to print, sign, and store the Declaration of Conformity. You may need to submit the Declaration of Conformity to the following entities:

1. Notified bodies

2. Amazon and other marketplaces

3. Fulfilment centres

4. Customs authorities

5. Market Surveillance Authorities

Do we need to send the Declaration of Conformity for approval?

Many companies are under the impression that a Declaration of Conformity must be approved or certified. This is not the case unless your product is subject to a Notified Body review. This is the case for certain types of protective equipment and medical devices, but not all products.

In all other cases, you will only create the Declaration of Conformity and store it in case it’s requested in the future.

Who may request a Declaration of Conformity in the EU?

The Declaration of Conformity may be required by the following entities:

Customs Authorities

The Customs Authorities can request a Declaration of Conformity when cargo arrives for customs clearance. National customs authorities in the European Union can seize and destroy, or force a return, if your product is non-compliant.

They also tend to request complementary test reports and label files to determine if your product is compliant.

That said, note that the customs authorities don’t always check the Declaration of Conformity. The lack of such requests in the past is not an indication of approval from their side.

Market Surveillance Authorities

Market Surveillance Authorities in various EU member states tend to check Declaration of Conformity documents in the following ways:

1. In cooperation with customs authorities

2. Random checks (which can happen after several months or even years)

3. When investigating reports of unsafe products

They also tend to request test reports and label files.

They also tend to request test reports and label files.

Marketplaces

Amazon and other marketplaces conduct checks of Declaration of Conformity documents either when a new product is listed or when carrying out checks.

Does Amazon require a Declaration of Conformity from sellers?

Yes, Amazon requires that products subject to CE marking requirements have a Declaration of Conformity. Amazon frequently removes products when sellers cannot provide a Declaration of Conformity and the supporting test reports.

Can we obtain a Declaration of Conformity from our suppliers?

If you buy from a company defined as a legal manufacturer, then yes. However, many non-EU manufacturers are not aware of EU Declaration of Conformity requirements. You should therefore not take their ability to do the following for granted:

a. Manufacturer products in compliance with EU standards, and;

b. Create an EU Declaration of Conformity

How much does a Declaration of Conformity cost?

The Declaration of Conformity itself doesn’t cost anything. However, if you intend to hire a consultant to create an EU DoC for you, then that can cost anywhere between 300 to 1000 EUR, depending on the complexity of the product.

Further, a Declaration of Conformity also requires that you declare which standards your product complies with. This must generally be verified through testing, which results in testing costs.

What is the difference between a test report and a Declaration of Conformity?

A test report is a document recording test results for a specific product, according to a set of regulations, directives, and standards. You must specify which standards your product complies with in the Declaration of Conformity. This can only be known if your product is tested.

As such, you must obtain a test report before you can make a Declaration of Conformity. That said, a test report is not a replacement or substitute for a Declaration of Conformity, but a complementary document.

Also note that Amazon and Market Surveillance Authorities often request test reports together with a Declaration of Conformity. A Declaration of Conformity alone is not sufficient evidence to demonstrate compliance.

Will the Declaration of Conformity be replaced by the Digital Product Passport in the EU?

The Toy Safety Regulation, which will replace the Toy Safety Directive, will replace the Declaration of Conformity with a Digital Product Passport.

At the time of writing, we don’t have any indication that this will be the case for all products subject to Declaration of Conformity requirements in the foreseeable future.