Product certificates are mandatory when importing a wide range of products to the European Union. In this article, we cover the basics of some of the most common European Union product certification documents, including relevant products, required information, and much more.
Declaration of Conformity (DoC)
The Declaration of Conformity (DoC) is mandatory for all products covered by one or more CE marking directives. As such, all businesses importing or manufacturing any of the following products need to issue a Declaration of Conformity:
- Medical devices
As mentioned, the DoC must be issued by the importer or manufacturing placing the product on the EU market. The DoC is not issued by a third-party, or government body.
The DoC may need to be presented upon arrival to the customs authorities, or whenever requested by market surveillance authorities or customers.
- Product identification/SKU
- Product features
- Name and address of the manufacturer/importer
- List of EN standards and/or EU directives
- Responsible individual
In addition to the Declaration of Conformity, importers and manufacturers must also prepare a technical file – which is a set of documents supporting the DoC. Here are some documents you may need to include in the technical file:
- Design drawings
- Technical drawings
- Packaging design files
- List of applicable directives/regulations/EN standards
- Test reports
- Quality control records
- User manual
- Risk assessment
You can buy requirements lists covering all recommended technical file documents on productip.com.
Declaration of Compliance
A Declaration of Compliance, not to be mistaken for the Declaration of Conformity, is mandatory when importing or manufacturing plastic food contact materials to the European Union. Here are some products which require a Declaration of Compliance:
Note that the Declaration of Compliance must be supported by a lab test report. Further, the Declaration of Compliance may need to be presented upon request by the customs authorities, market surveillance authorities or customers.
1. Identity and address of the business operator issuing the declaration of compliance
2. Identity and address of the business operator which imports the product
3. Identity of the materials, the articles, products
4. Date of the declaration
5. Declaration of compliance with applicable regulations (e.g. EC No. 1935/2004)
6. Adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions
7. Adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC* to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food
- Types of food (which the product is made to be in contact with)
- Time and Temperature
- Ratio of food contact surface area to the volume used to establish the compliance of the material or article:
9. Functional Barrier
How do I get my products certified?
The EU generally doesn’t use the term ‘certification’ but ‘declaration’. This is also an accurate description of its purpose – which is a self-issued statement ‘certifying’ or ‘declaring’ that a certain product is compliant with the specified product regulations and standards.
As such, product certificates are, in most cases, self-issued by the importer (when the product is manufactured outside the EU) or a European manufacturer.
The challenging aspect lies in that it can be difficult to understand what information to include in a Declaration of Conformity or Declaration of Compliance.
The required information can be found on the EU website and the websites of relevant national authorities. However, most importers and manufacturers still need assistance from a consultant or service provider to make sure they get it right.
What’s the difference between a product certificate and a test report?
Product certificates, such as the Declaration of Compliance, is a self-issued ‘compliance statement’. Test reports, on the other hand, only covers test data and the result. The purpose of the test report is often to support the statement in the product certificate.
Do I need to send the product certificate for approval?
Product certificates, and support documents such as test reports, are generally not submitted for approval. However, all mandatory compliance documents must be in order before the product is placed on the market.
Keep in mind that the authorities can request compliance documents upon arrival, or months after you’ve started selling your products in the European Union.
What can happen if I don’t have a product certificate?
Failing to produce, for example, a Declaration of Conformity can result in major fines or forced recall.
Is product certification mandatory in the EU?
Compliance documents, including those mentioned in this article, are only mandatory for certain products. There’s not a single product certification requirement applicable to all products imported and sold in the EU.
Do I need product certification to sell on Amazon in Europe?
Amazon requires that you can provide all mandatory compliance documents in each respective market/country. This is also the case when selling on Amazon in Germany, France, Italy or elsewhere in the European Union.
For example, Amazon is likely to require that you supply a Declaration of Conformity when selling electronics, toys and other ‘CE marking’ products. Failing to provide a DoC may result in your products being suspended immediately.
Can we get a product certificate from our supplier?
Product certificates must generally be issued by the importer, not a manufacturer outside the European Union. Further, the vast majority of manufacturers outside the EU don’t have the knowledge required to create a Declaration of Conformity or Declaration of Compliance. Asking them to do so for you is highly risky.