/También disponible en español.
You have a good product, approved and selling at home, and you want to enter the European Union. The first surprise is usually this: your local approval does not make you EU-legal. Not ANMAT, not INVIMA, not ANVISA, not your national health registration — none work in Europe on their own. The EU has its own framework, and it must be met, regardless of what you already hold. Here is what it actually requires and how to enter without stumbling.
Your local certification is not (automatically) valid in the EU
It is the costliest assumption when planning to export to Europe: that a product approved at origin goes straight in. It does not. Just as a Chinese (GB) or US (FDA) test does not equal the European requirement, an authorisation from ANMAT (Argentina), INVIMA (Colombia), ANVISA (Brazil), ISP (Chile) or COFEPRIS (Mexico) does not replace compliance with the EU regulation that applies to your product. It can serve as supporting evidence — and we use it — but conformity is proven against the European framework.
What the EU does require: a responsible person established in the Union
The point that most holds back a non-EU exporter is this: to place a product on the European market there must be an economic operator established in the EU that answers for the product. You cannot do it from Latin America without that figure. By product type:
- Cosmetics — a Responsible Person established in the EU (Regulation (EC) 1223/2009): the importer is one, or designates one by written mandate. Plus CPNP notification before marketing.
- General consumer products — a responsible person in the EU (GPSR, Regulation (EU) 2023/988, art. 16), and CE marking if the product falls under a CE directive. See does my product need CE marking?
- Medical devices — an Authorised Representative in the EU (MDR, Regulation (EU) 2017/745, art. 11), plus CE marking.
- Food supplements and food — an EU-established operator (importer) and the notification/registration required in the country of entry.
And labelling, in the country’s language
The product must arrive with compliant labelling in the language of the country where it is sold (or of each country, if you sell in several), with the EU responsible person’s details, warnings and instructions. Latin-American Spanish labelling does not always meet the requirements of the European market of destination.
How we enter the EU with you
We do not hand you a list of requirements and wish you luck. We determine the framework that applies to your product, build the European file using the evidence you already have from your country (mapped to the EU requirement), arrange the EU responsible person/representative and prepare the labelling. An ASC technician reviews and signs it. It is not an app that leaves the liability with you 10,000 km away: it is an operated service, with someone who answers in Europe. Twenty years and hundreds of dossiers.
Frequently asked questions
My product is approved by ANMAT/INVIMA/ANVISA — is that enough for the EU? As supporting evidence, yes; as conformity, no. The EU requires its own framework. We use your tests and approvals where admissible and close what is missing.
Can I sell in the EU without a company there? You need an EU-established responsible economic operator (importer, responsible person or authorised representative, depending on the product). We help you solve that figure.
Do I have to redo all the testing? Not necessarily. Often it is resolved by mapping your evidence to the European requirement, by worst-case calculation or by scoping to the real use. Only what is genuinely missing is tested.
Is Spanish labelling enough? It depends on the country of destination: it must meet that country’s rules and be in its language. We adapt it per market.
Tell us your product and your market
Tell us what you want to sell in the EU and which country you export from, and we will tell you what Europe requires and how to enter.
Want a quick answer? Start with the Express Advisory: in 48-72 h we tell you whether your product can be sold in the EU and what it needs. Reach us through our contact page.