A founder asked us last month: “We registered our supplement in Germany. Can we sell in France now?” The honest answer: probably yes, with caveats, and definitely not in every other EU market without more work. Here’s the practical reality of multi-market nutra registration.
The myth of “one EU registration”
The EU sets the framework via Directive 2002/46/EC, but each of the 27 member states transposes that directive into national law and runs its own notification procedure. Germany’s BVL works one way, Italy’s Ministry of Health another, France’s DGCCRF another. Belgium and Netherlands have particularly strict ingredient lists.
What’s universal: the principle of mutual recognition. A product legally sold in one EU market generally has a path to sell in others, but you usually still need to notify each market’s authority that the product is being placed on its market.
The four notification archetypes
1. Notification with submission of documentation
Italy, Belgium, France, and several others require you to submit a complete dossier (label, formula, scientific substantiation for any claims) and wait for an authority response. Timelines: 30–90 days.
2. Notification only (no documentation review)
Some markets require you to notify, providing a link to the label and product details, but the authority does not pre-review. You can market immediately upon notification. Timelines: same week.
3. No notification (mutual recognition only)
A few markets accept products legally placed in another EU state without their own notification. You hold a Mutual Recognition Declaration on file in case challenged.
4. Cosmetics (different framework entirely)
For cosmetic creams (our ISO 22716 line), the EU runs the Cosmetic Products Notification Portal (CPNP). One central notification + a Cosmetic Product Safety Report (CPSR) signed by a qualified Safety Assessor. Faster than supplements: typically 1–2 weeks.
How a “file once” workflow actually works
Here’s how PharmScale’s regulatory team handles a brand entering multiple EU markets:
- Master dossier built once: formula, manufacturing flow, finished product specification, stability data, allergen statements, supplier qualification, certificate of analysis template.
- Per-market label adaptation: the master label is translated and adjusted per local law (Belgian labels need French + Dutch + German, for example).
- Per-market filing: our regulatory team submits the local notification with the adapted label and your dossier.
- Authority follow-up: if any market raises questions, we respond on your behalf.
- Active dossier maintenance: we keep the dossier current as your formulation evolves.
Total work for entering a new market after the master dossier is built: usually 2–6 weeks per market. The first market is the heaviest lift.
The U.K. is its own thing now
Post-Brexit, the U.K. operates separately. Supplements need to comply with U.K. law (largely retained EU regulation but diverging). Cosmetics use the U.K. SCPN portal instead of CPNP. We file U.K. notifications as a separate workstream.
What this means for your product brief
When you tell us “I want to launch in EU + U.S.”, we ask which specific countries and which order. There’s a meaningful difference between “all 27 EU + U.K. + U.S.” and “Germany + France + U.S.”. Most first-time brands launch in 2–4 specific markets and expand later. A pragmatic order:
- Your home market (where your customer base lives)
- One adjacent EU market for cross-border learning
- U.K. if you have English-language demand
- U.S. once your branding and assets are battle-tested in EU
Or: file all 27 EU + U.K. + U.S. simultaneously if you have the budget and the demand to support it. We’ll do either.