Supplements × EU
Private label supplements for the European Union
The EU harmonises the label and the claims but not the dose. A vitamin level that sells in one Member State can be refused in the next, and some countries want your product notified before it goes on sale.
Private label supplements in Europe: one framework, national details
To launch private label supplements in the EU, you need a food business operator established in the Union, vitamins and minerals taken only from the harmonised lists in Annex I and Annex II of Directive 2002/46/EC, a label that meets both that directive and the food information rules of Regulation 1169/2011, and only health claims authorised in the EU Register under Regulation 1924/2006. Member States may also require notification of each product to their competent authority under Article 10 of the directive, so your country list decides much of the paperwork.
Maximum amounts are where the single market stops. The directive foresees EU-wide minimum and maximum levels for vitamins and minerals, but the Commission states that no proposal has been presented yet because views diverge. National limits and practice therefore still apply, and a high-strength product may need a different formula per country. Rules for botanicals and other substances also differ between countries, and any food not consumed to a significant degree in the EU before 15 May 1997 is a novel food that must be on the Union list before sale.
Small formulation details matter too. Titanium dioxide (E171), once a common white colour in tablets and capsule shells, has been banned as a food additive since 2022 under Regulation 2022/63, and the Commission names food supplements among the products that used it. Our EU market guide covers product safety, packaging and channels, and the supplements category page sets out the claim-first logic. We give this as general information, and a licensed EU food law specialist checks every formula, label and country list during the project.
EU requirements for a private label food supplement
Union rules first, with the national layer shown where it applies.
| Requirement | What it means | Who is responsible | Timing or cost driver |
|---|---|---|---|
| Vitamins and minerals | Only nutrients listed in Annex I, made from sources listed in Annex II | Formulator and operator | Imported formulas may use forms that are not on the list |
| Dose levels | No harmonised maximum levels yet; national limits and practice apply | Operator in each country of sale | Different strengths or SKUs per country |
| Novel foods | Union list authorisation for foods without significant EU consumption before 15 May 1997; consult the authority of the first country of sale if unsure | Operator | Authorisation is a separate, slow project |
| National notification | Article 10 allows countries to require notice of each product placed on their market | Operator selling in that country | Procedure and timing set nationally |
| Label | Name ‘food supplement’, nutrient categories, daily portion, warning not to exceed it, varied diet statement, storage out of reach of young children, plus general food information rules | Operator | One artwork per language group |
| Health claims | Only authorised claims from the EU Register, used under their conditions; no disease claims | Operator and anyone advertising | Claims wording fixed per language |
The EU Register lists authorised and non-authorised health claims.
Before the first batch is placed on the EU market
One product, one or more Member States.
- EU operator or importer appointed, named on the label, with a contract that sets out the role
- Each vitamin and mineral form checked against Annex II, and each dose against the limits of every target country
- Novel food status confirmed for botanicals and newer ingredients, with evidence kept on file
- Label with all mandatory supplement statements and food information, in the language of each country of sale
- Claims list matched to the EU Register, including the conditions of use
- National notifications filed where the country requires them
- EU trademark filed before artwork is final, as explained in EU trademark registration
Launch sequence for an EU supplement brand
We date national steps per country, since each authority sets its own procedure.
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1
Pick the first countries
Start with one or two Member States.
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2
Screen the formula
Check forms, doses, novel food status and additives against EU and national rules before design starts.
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3
Choose the manufacturer
An EU producer simplifies the food business chain; one outside the EU adds an importer and import checks. Our <a href="/services/private-label-manufacturing/">manufacturing stage</a> compares selected contract manufacturers on food safety evidence, minimums and label handling.
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4
Claims and label
Fix claims from the EU Register, then write the label per language.
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5
Notify where required
File national notifications for each country that requires them.
Timing set by each national authority
Frequently asked questions
Do I need approval to sell food supplements in the EU?
Not product by product at EU level, unless an ingredient is a novel food needing authorisation. Countries may require notification of each product under Article 10 of Directive 2002/46/EC, and the operator must meet composition, labelling and claims rules before sale.
Are maximum vitamin levels the same across the EU?
No. The directive provides for harmonised maximum and minimum levels, but the Commission says no proposal has been presented yet. National limits and practice apply, so a dose accepted in one country can be refused in another.
Can a non-EU brand sell supplements in the EU?
Yes, through an operator established in the EU, either its own entity or an importer. The label shows that operator’s name and address, and the operator answers for compliance in the countries of sale.
Which health claims can an EU supplement use?
Only claims authorised in the EU Register of nutrition and health claims, with their conditions of use. Claims to prevent, treat or cure disease are prohibited for supplements, and claims listed as non-authorised cannot be used.
Have a product idea? Check it before you buy stock.
Send a short brief. We tell you what we think, including when we think you should not do it.
Tell us about your brand
A few lines are enough: what you want to sell, where and to whom. We reply with an honest view of feasibility, the stages you need and the next step.
- No obligation: the first review of your idea is free
- If we think the idea will not pay back, we say so
- Your idea stays confidential; we can sign an NDA
What happens next
- 1We review your briefand may ask a few questions
- 2A short callabout goals, budget and limits
- 3Written proposalstages, scope, fees and timing
- 4First stage startswith a decision gate at its end
- usually 300–1 000 units per product in a first order
- usually 6–12 months from brief to first sales
- EU company, contract under Polish law