Food Supplements,
Made Simple

Can I sell the same supplement formulation across every EU country with one label?

Not automatically. EU-wide rules like Regulation (EC) 1924/2006 on health claims and the Novel Food Regulation set a common baseline, but individual member states can apply their own maximum permitted levels for vitamins and minerals and their own notification requirements before a product can be sold. We map out where your formulation needs country-specific adjustment rather than assuming one label works everywhere.

Do all EU countries require you to notify them before selling a supplement?

No, but a significant number do, and it's one of the most commonly missed steps for brands entering the EU. Several member states require formal notification, sometimes with a fee or specific dossier, before a supplement can legally go on sale within their borders. We handle member-state notification as part of our EU service, so you're not caught out market by market.

What's the difference between EFSA approval and getting my supplement onto the market in the EU?

EFSA carries out the scientific risk assessment behind EU-wide rules, such as novel food evaluations and the health claims permitted under Regulation (EC) 1924/2006, but EFSA doesn't approve individual products for sale. Getting your specific supplement to market is about proving your formulation, labelling and claims comply with that framework, and clearing any member-state notification, in each country you're targeting.

Are vitamin and mineral maximum levels the same across the EU?

No, this is one of the biggest traps for brands expanding across Europe. While Regulation (EC) 1925/2006 sets the framework for fortification, individual EU member states set their own maximum permitted levels for many vitamins and minerals in supplements, so a dose that's fine in one country can breach limits in another. We check your formulation against each target country's limits before you commit to a pan-EU launch.

What health claims am I actually allowed to put on an EU supplement label?

Only claims that appear on the EU Register of Nutrition and Health Claims, and only when your product meets the conditions attached to that claim, such as minimum nutrient levels. Anything implied or generic that isn't backed by an authorised claim under Regulation (EC) 1924/2006 is a compliance risk. We review every claim on your packaging and marketing against the register before launch.

Do I need a novel food authorisation to sell my supplement in the EU?

Only if your ingredient falls under the Novel Food Regulation (EU) 2015/2283, meaning it wasn't consumed to a significant degree in the EU before 15 May 1997. This catches more ingredients than people expect, including some botanical extracts and novel ingredient forms. If yours qualifies, it needs authorisation before sale, and we assess this early so it doesn't delay your EU launch timeline.

Do food supplement labels need to be in the local language of each EU country I sell in?

Yes. While your formulation, safety documentation and much of your claims evidence can stay consistent across the EU, mandatory label information such as usage instructions, warnings and the ingredients list need to appear in the official language of each member state where the product is actually sold. That means a label built for one EU country often needs local-language versions before it can go on shelves elsewhere.

Still have questions? Contact us and we'll be happy to help.