Declaration of mutual recognition
Do you already sell goods in one EU country and want to start selling them in another?
In principle, a product authorised for sale in one EU country is authorised for all EU countries. In practice, the authorities in another EU target country might ask for additional information before authorising you to sell your products. A mutual recognition declaration can help you provide that information.
This voluntary self-declaration allows producers, importers and distributors to show to authorities that their goods comply with the rules in another EU country, where are already being sold.
The declaration covers all ‘non-harmonised' goods of any type – meaning goods that are not covered by EU-wide legislation, which sets common requirements. It can be also used for agricultural goods.
How a mutual recognition declaration can help you
If there is no prior authorisation procedure for your product, you are free to begin selling it in another EU country. Authorities in that country do have the right, however, at any time, to decide to assess goods you have begun selling. They will inform you in writing:
- what goods of yours will be assessed
- what technical rules or authorisation procedures apply to them
- whether you can use the mutual recognition declaration to demonstrate that your goods are already authorised for sale in another EU country
You can choose to submit or not submit the declaration:
If you submit a complete mutual recognition declaration, including supporting evidence, the authority carrying out the assessment cannot request any further information or documentation from you.
If you do not submit a mutual recognition declaration, the authority may request that you provide documentation that:
- describes the characteristics of the goods or type of goods
- proves that that goods have been lawfully marketed in another EU country
The authorities must give you at least 15 working days to prove that your goods can be lawfully sold in their country.
During the assessment period, you can still sell your products freely. You will only have to stop if you receive an administrative decision restricting or denying access to the market for the products concerned.
How to write a mutual recognition declaration
The declaration consists of two parts, described in detail in the EU regulation. There are 2 possibilities regarding the drafting:
- the producer (or representative) fills out Part I, and the importer/distributor fills out Part II.
- the importer/distributor fills out Parts I and II (if they can supply evidence supporting the information in the declaration).
Part I – information about the goods
Part I describes the goods and any applicable rules in the EU country where they are already being sold. It must contain:
- A number or other reference marker that uniquely identifies the goods or type of goods
- Name and address of the producer, importer or distributor filling out Part I of the declaration
- Description of the (type of) goods, sufficient to enable them to be identified for traceability reasons. This can include a photograph.
- Declaration that the goods:
- have already been lawfully sold in EU country X (give the title and official publication reference of the relevant rules and/or authorisation decision); or
- are not subject to any relevant rules in EU country X
- Reference information for any conformity‑assessment procedure or test undergone by the goods (including the name and address of the assessment body)
- Any other documentation showing the goods have already been lawfully sold in EU country
Signature of the producer, importer or distributor identified in point 2 above:
Signed for and on behalf of:
(place and date):
(name, function) (signature)
Part II – information about the selling of the goods
Part II focuses on the selling of the goods. It must contain:
7.1 EU country in which the goods are already sold (as indicated in 4.1)
7.2 Date on which the goods were first sold in that country. For example, you can prove this by attaching an invoice.
8. Any additional information that can help the authorities assess whether the goods are already being lawfully sold in EU country X.
9. Signature of the producer, importer or distributor who has filled out Part II
Signed for and on behalf of:
(place and date):
(name, function) (signature)
Language regime
The mutual recognition declaration must be drafted in one of the official EU languages. National authorities can require you to translate it into the language of their choice.
Warning
Keep it updated!
You must always have an up‑to‑date version of the mutual recognition declaration.
Were your products denied access?
If you think that national authorities have wrongly refused or restricted your products' access to their country's market, you can request assistance from SOLVIT.