Launching a food supplement in the EU, in seven steps.

Classify the product

In EU law a food supplement is a food that supplements the normal diet and is a concentrated source of nutrients or other substances with a nutritional or physiological effect, sold in dose form: capsules, tablets, sachets, measured liquids and similar (Directive 2002/46/EC, Article 2).

The line to watch is the one to medicinal products. A product that claims to treat or prevent disease, or that acts like a drug (pharmacologically), falls under medicines law instead. Borderline cases, such as some plant ingredients (botanicals) or very high doses, are decided by national authorities.

Check every ingredient

• Vitamins and minerals may only be used in the chemical forms listed in the annexes of Directive 2002/46/EC. Maximum amounts are not yet harmonised at EU level, so member states apply their own limits or recommendations. A dose that is accepted in one country can be too high in another.
• Novel Food. An ingredient that was not consumed to a significant degree in the EU before 15 May 1997 needs authorisation under Regulation (EU) 2015/2283. Check the Union list of authorised novel foods before you formulate.
• Plant ingredients (botanicals) are regulated nationally. Several countries use positive or negative lists, for example the joint BELFRIT list of Belgium, France and Italy.
• Microorganisms. Check each strain’s safety status, for example on the QPS list (Qualified Presumption of Safety) of EFSA, the European Food Safety Authority, and whether it counts as a novel food. Our strain catalogue explains how we handle this.
• Contaminants. Maximum levels for lead, cadmium and mercury in food supplements are set in Regulation (EU) 2023/915.

Get the claims right

Every health claim on a label, a website or in an advert must be authorised and listed in the EU Register (Regulation (EC) 1924/2006). The permitted general health claims (“function claims”) are listed in Regulation (EU) 432/2012, each with conditions of use. For vitamins and minerals, the product usually has to provide at least 15% of the nutrient reference value (NRV) per daily dose.

• Disease claims are forbidden for foods: no claims to prevent, treat or cure a disease.
• Claims for plant ingredients: roughly 2,000 are still “on hold” (awaiting a decision) at EU level. Whether they can be used depends on national practice.
• “Probiotic”: the European Commission treats the term as implying a health benefit, and no claim for probiotics is authorised. Many member states therefore do not accept it on labels; German case law has treated such terms as health claims (Federal Court of Justice, I ZR 178/12). A few member states allow it under national rules.
• Postbiotics: no authorised claim exists either. Describe the ingredient factually.

Build a compliant label

Regulation (EU) 1169/2011 and Directive 2002/46/EC together require, among other things:

• the name “food supplement” in the local language (for example “Nahrungsergänzungsmittel”), with the categories of nutrients or substances that characterise the product;
• the recommended daily dose, a warning not to exceed it, a statement that food supplements are not a substitute for a varied diet, and a statement to keep the product out of reach of young children;
• the amount of each nutrient or substance per daily dose, and for vitamins and minerals also as a percentage of the reference intake;
• the ingredient list with allergens highlighted, net quantity, best-before date, storage conditions and the batch (lot) number;
• the name and address of the responsible food business operator in the EU;
• a minimum font size of 1.2 mm x-height (the height of a lower-case “x”) for mandatory text (0.9 mm if the largest surface is under 80 cm²), in a language consumers in each country understand.

Name the responsible company

The food business operator under whose name the product is marketed is responsible for the label information; if that business is outside the EU, the importer into the EU takes that role (Regulation (EU) 1169/2011, Article 8).

For brands from the Gulf states (GCC), Asia or the UK this is the step most often missed: you need an EU-based company whose name and address go on the pack and who answers to the authorities. Plan it before you print.

Notify the authorities

Directive 2002/46/EC allows member states to require a notification when a food supplement is first placed on their market, usually by sending a model of the label. Many do. Examples:

Manufacture, document, release

The manufacturer must run a food safety system based on HACCP principles (hazard analysis and critical control points; Regulation (EC) 852/2004), and every business in the chain must be able to trace each batch one step back and one step forward (Regulation (EC) 178/2002, Article 18).

In practice that means a written specification before production, verified raw materials, a Certificate of Analysis for every batch, a stability plan so the declared values hold to the end of shelf life, and a technical file ready for inspections and retailers. Our manufacturing page shows how we do it.

Typical timelines: 1–2 weeks for formulation, 3–4 weeks to pilot samples, 8–10 weeks from brief to the first production run. Minimum orders start at 500 units per SKU for sports nutrition and 60,000 capsules for probiotics.

Before the first pallet ships

• Product classified as a food supplement, not a medicine
• Every ingredient permitted, in a permitted form and dose, for every target market
• Novel Food status checked for each ingredient, including strains
• Claims authorised, conditions of use met, no disease claims
• Label complete, in the right languages, with the right font size
• Responsible EU company or importer named on the pack
• National notifications filed
• Specification, Certificate of Analysis, stability plan and technical file in place

This guide gives general information on EU rules as of September 2026. It is not legal advice. National rules change; check the current law, or ask us for the requirements of your target markets.