
Supplements manufactured in the EU and sold outside it
This is the part of the job that almost no manufacturer writes down, so brands find it out late and expensively. Inside the EU a food supplement is notified, not approved. Outside it, nothing carries over automatically: the product is registered locally, and the registration is held by someone established in that country.
What comes with the order
- What we supply: the specification, the full ingredient and allergen declaration, the Certificate of Analysis for the batch and the site certificates with their numbers
- What the destination adds is local: a registration holder, a technical representative, sometimes pre-shipment inspection
- “Made in the EU” is a selling point, not a shortcut through registration
- Tell us the destination market at the enquiry stage — it can change the label, the pack and the documents
Notified is not the same as approved, and the difference travels badly
In the European Union a food supplement is placed on the market by notifying a national authority; nobody assesses and approves the product first. That is efficient inside the single market and it is the source of the most expensive misunderstanding in export: a brand assumes an EU product has been vetted, and presents that to a regulator who works the other way round. Most markets outside the EU register the product itself, review the dossier and issue a number before a single unit may be sold.
The registration is held locally, and that is not a formality
Several markets require the holder of the registration to be established in the country. Morocco registers supplements through its own authority, Egypt works through a pharmacy channel with its own document legalisation chain, and Kenya requires a local technical representative alongside pre-shipment verification of conformity. None of this can be done by the factory, and any manufacturer who says otherwise is selling you something they cannot deliver. What the factory can do is supply a dossier that the local filing is actually built on, complete and consistent, the first time.
Decide the market before the label, not after
Ingredient limits, permitted claims, language requirements and pack sizes differ by destination, and a label designed for the EU rarely survives the move unchanged. Naming the market at the enquiry stage costs nothing; discovering it after ten thousand labels are printed costs the print run and the season.
Frequently asked questions
Can you register our product in a market outside the EU?
No, and no manufacturer can. Registration abroad is held by a local entity: an importer, a registration holder or a technical representative established in that country. We supply the specification, the analysis and the site certificates the filing is built on.
Does a supplement need approval before sale in the EU?
No. Food supplements in the EU are notified, not approved. The company named on the label files a notification with its national authority before sale; in Spain that authority is AESAN. The composition and batch documentation come from us.
Which documents do you provide for an export dossier?
The product specification, the full ingredient and allergen declaration, the shelf-life statement, the Certificate of Analysis for the batch and the site certificates with their numbers: ISO 22000:2018 MSC-22-1384, GMP-FS-01, HACCP-01 and US FDA registration 13674831934.
Does “made in the EU” speed up registration abroad?
It helps commercially and it does not replace a local filing. Because EU supplements are notified rather than assessed, an EU origin is not evidence that a product has been reviewed, and regulators outside the EU treat it that way.
More on who we manufacture for: all six kinds of buyer.
Get a quote for your quantity
Tell us the format, the active, the dose and how many units you need for the first run. You will get a price for that quantity and for a larger one, so you can see where the unit cost goes.
- Phone
- +34 637 48 95 63
- Office
- Calle Nuestra Señora de Gracia 7, Planta 2, puerta C
Marbella, Málaga, Spain - Production
- “Kargo k-1”, Mārupe, LV-2167, Latvia