This post is by Ferry Vermeulen, Founder of INSTRKTIV, a company which helps businesses develop compliant product documentation and user manuals.
When selling certain products on Amazon in Europe, the platform requires you to submit a Declaration of Conformity. A Declaration of Conformity (or DoC) proves that the product complies with European product safety legislation.
Depending on the EU directives that apply to your product, there are different requirements on the content of the Declaration. Amazon is very strict and only approves products that include a compliant Declaration. They often decline products without giving a reason, so the seller has to work out what’s missing for themselves.
This article will explain what a Declaration of Conformity is, when you need one, and how you can draft and submit a compliant DoC.
- What is a Declaration of Conformity?
- What kind of products require a Declaration of Conformity?
- When does Amazon ask sellers for a Declaration of Conformity?
- Why does Amazon ask for a Declaration of Conformity?
- How do you get a Declaration of Conformity for a branded product?
- How do you get a Declaration of Conformity for your own brand or private label product?
- What are the steps towards EU compliance?
What is a Declaration of Conformity?
The Declaration of Conformity formally declares that a product complies with the relevant European product health and safety directives. The manufacturer must draw up and sign the DoC. By doing so, the manufacturer takes full responsibility for the product’s compliance with applicable product safety legislation.
The DoC is the last step in the CE marking process and only applies to products that fall within the scope of CE marking. See What are the steps towards EU compliance? below for more information about the CE marking process.
What kind of products require a Declaration of Conformity?
All products that are subject to CE marking require a Declaration of Conformity. CE marking is mandatory for certain product categories that are sold within the European Economic Area. These include, amongst others, electronics, toys, sunglasses and mechanical fitness equipment.
Toys, for example, must comply with the Toy Directive. Electronics need to comply with the EMC, RoHS and possibly the LVD Directive. Sunglasses fall within the scope of the Directive on Personal Protective Equipment.
Simple fitness equipment such as kettlebells and resistance bands are not subject to CE marking. However, most cardio fitness equipment, such as treadmills, bikes, steppers, cross-trainers and climbers are governed by European CE Directives such as the Machinery Directive, EMC, LVD RoHS and/or ErP Directive. Several directives may apply to a single product.
All these products can only legally be placed on the market when they have been tested, have a complete technical file, and bear a CE mark to demonstrate compliance with the relevant directives and harmonized standards.
When does Amazon ask sellers for a Declaration of Conformity?
Certain products, including most regulated within the European Union, are classified by Amazon as requiring “pre-approval”. These products include, but are not limited to, kitchen equipment, toys, lighting, batteries and chargers. For these, Amazon requires you to upload the Declaration of Conformity before the product can be sold.
To request pre-approval, you should do the following:
- Go to Catalog > Add Products in Seller Central.
- Enter the ASIN or other product code in the search box.
- Click Listing Limitations apply and Request Approval under the product information.
- Upload the required documentation.
- Submit the application.
Within a few days, Amazon will either approve your application or reach out for more information.
If you don’t request approval up front, Amazon can stop you selling the product at any time and request the Declaration of Conformity be uploaded. If you don’t have one, or they do not accept it, you will not be able to sell the product again.
Why does Amazon ask for a Declaration of Conformity?
Amazon wants to ensure that only safe products are sold on their marketplace. They also want to make you aware of the fact that you, as the seller, are fully responsible for the product. It is the seller who should make sure that the product complies with all relevant safety regulations.
In fact, as soon as you import products into the European Union, you should already include a copy of the DoC with the product, or hand it over to customs upon request. Customs can hold products if they do not contain a compliant declaration.
Products which are NOT regulated by CE marking directives (for example inflatable beds, pens and furniture), must still comply with the General Product Safety Directive, requiring that all products placed on the European market should be safe. Amazon’s terms also require sold products to be safe and comply with national product regulations.
How do you get a Declaration of Conformity for a branded product?
When you sell a branded product from another company, you are seen as a distributor of the product within the European Union. A distributor can be any business, including a retailer or wholesaler, that acquires products for further distribution. They may have sourced these products from another distributor, an importer or directly from the manufacturer.
It is the responsibility of the distributor, before making a product available on the market, to verify that:
- The product bears the required conformity markings, such as CE marking.
- The relevant documents are included with the product e.g. the Declaration of Conformity, user instructions and safety information.
- The product shows the name of the manufacturer or importer, their registered trade name or trademark, product type, batch or serial number, and the address at which they can be contacted.
Sometimes it is not possible to include the information above on the product itself, for example due to the product’s size or the type of material it is made from. In this case, the information can be included on the product’s packaging and/or in the user instructions.
So, for all branded products, you as the distributor should make sure that the products are accompanied by a compliant Declaration of Conformity. When selling the product on Amazon, upload the DoC when requested during the pre-approval process.
How do you get a Declaration of Conformity for your own brand or private label product?
When you have your own brand or private label product and sell it within the EU, you are legally seen as the manufacturer of the product. Therefore it is your responsibility to ensure that the product complies with all relevant legislation.
This means that you must draw up the Declaration of Conformity, declare that the product complies and take full responsibility. Depending on the type of product, there are different requirements for the content of the DoC.
To draw up a compliant Declaration of Conformity:
- Make sure that your product complies. See below.
- Determine the applicable directives for your product.
- Download a free DoC template for your main directive.
- Fill in the template.
The DoC needs to be signed by the person who placed the product on the European market. A DoC signed by a Chinese manufacturer, for example, would not be accepted!
What are the steps towards EU compliance?
As discussed previously, the Declaration of Conformity is just the last step in the CE marking process. By signing it, you declare that the product meets all requirements of the relevant CE Directives.
So what does the CE marking process look like? It always consists of the following six steps:
- Identify the applicable directives and harmonized standards.
- Find the product-specific requirements of each applicable directive.
- Decide whether an independent conformity assessment (by a notified body) is necessary.
- Test the product and check its conformity.
- Compile and keep available the technical file. Each directive has different requirements on the content of the technical file.
- Add the CE mark and draw up the EU Declaration of Conformity.
If you have any questions about CE Marking and the Declaration of Conformity, please let me know in the comments.
This post was by Ferry Vermeulen, Founder of INSTRKTIV. INSTRKTIV helps exporters, importers, distributors, designers and manufacturers of products to develop compliant documentation and also supports them in the certification process. Ferry has also written about creating compliant user instructions.