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EU supplement regulatory and compliance support
Selling a supplement in the EU means meeting a specific set of rules, and getting them wrong can pull a product from sale. Vita, an EU contract manufacturer in Ljubljana, Slovenia, builds compliance into the product before it ships. We word benefit claims against the EFSA health-claims register, using authorised supports and contributes to language and never disease claims. We check ingredients for novel food status, confirm doses sit within permitted maximum levels, and lay out labels to meet EU food information rules. Because notification requirements differ by member state, we help you understand what each target market expects before launch. The work happens alongside formulation and labelling, so the product is compliant by design rather than corrected after the fact. That keeps your launch clean across the single market. Send your product and target countries and you get a quote within 24 hours.
Last updated 28 Jun 2026
- Tested & documented Certificate of analysis per batch
- Made in the EU Ljubljana, Slovenia
- Low MOQ from 100 Test before you scale
- 24-hour quotes A real person replies
How it works
- 1
Review formula and target markets
We look at your ingredients, doses and the countries you plan to sell in, then map the rules that apply to each.
- 2
Check ingredients and levels
Each ingredient is checked for novel food status, and every dose is confirmed against permitted maximum levels for the EU.
- 3
Word the claims
Benefit claims are aligned with the EFSA register using authorised wording, with no disease claims, so the label holds up under scrutiny.
- 4
Build compliant labelling
Labels are laid out to EU food information rules, with all mandatory fields, allergens and panels in place.
- 5
Guide notification
We explain what each target market expects for notification, so you know the steps before you place product on sale.
What you get
- EFSA-aligned claim wording for your products
- Novel food status check on ingredients
- Maximum-level confirmation on every dose
- EU-compliant label layout and mandatory fields
- Per-market notification guidance
- Compliance built in before launch, not corrected after
What EU compliance actually covers
Four things decide whether a supplement can legally go on sale in the EU. Claims must come from the EFSA authorised register and avoid any disease language. Ingredients must clear novel food rules or hold the right authorisation. Doses must respect maximum permitted levels. Labels must meet EU food information rules. On top of that, each member state has its own notification process before product hits the market.
- EFSA register: only authorised health claims, in approved wording
- Novel foods: ingredients without a significant pre-1997 history need clearance
- Maximum levels: doses kept within permitted limits
- Labelling: mandatory fields, allergens and panels per EU rules
- Notification: requirements that differ by member state
Compliant by design, not by correction
Fixing a non-compliant product after it is made is expensive and slow. We check claims, doses and ingredients during formulation and labelling, so the product is right before the first batch runs. That is how a launch stays clean across Slovenia, Germany, France and the wider single market.
Frequently asked questions
Can you make sure my claims are legal in the EU? +
Yes. We word benefit claims against the EFSA health-claims register using authorised supports and contributes to language, and we avoid disease claims entirely.
What is a novel food and why does it matter? +
A novel food is an ingredient without significant consumption history in the EU before 1997. It needs authorisation before sale, so we check ingredient status during formulation.
Do you handle notification in each country? +
Notification rules differ by member state. We guide you through what each target market expects so you know the steps before placing product on sale.
How do you keep doses compliant? +
We confirm every dose sits within the permitted maximum levels for the EU, checked during formulation before any batch is produced.
Get your 24-hour quote
Tell us what you want to make. You get a costed quote, MOQ and lead time from a real person within 24 hours, no obligation.
Made in the EU · Ljubljana, Slovenia · MOQ from 100 units