The European Union harmonises the basic definition of a food supplement across its member states, but a Japan-made product still meets national rules at the border of whichever country receives it first — different notification steps, different label languages, and sometimes different maximum nutrient levels.
This guide covers what Directive 2002/46/EC actually harmonises, why many member states still require their own notification, when a Japanese ingredient needs Novel Food authorisation, how the EU health claims register works, and why label language and nutrient maximums stay a national matter.
💬 Planning to bring a Japan-made supplement into the EU? We help you map which of these steps apply to your formula and your first market. See Japan-made supplement OEM.
What Directive 2002/46/EC actually harmonises
Directive 2002/46/EC sets a common EU definition of a food supplement and a common list of permitted vitamins and minerals, but leaves several important decisions — including notification and maximum nutrient levels — to each member state.
| Element | What the Directive covers |
|---|---|
| Definition | A concentrated source of nutrients or other substances with a nutritional or physiological effect, sold in dose form (capsule, tablet, and similar) |
| Permitted vitamins/minerals | Annex I lists the vitamins and minerals that may be used; Annex II lists the permitted sources (forms) of each |
| Substances not on the list | A vitamin or mineral form not on Annex I/II generally cannot be used in an EU food supplement |
| What is left to member states | Maximum and minimum levels of vitamins and minerals, and whether to require notification before sale |
Because the Directive only harmonises the basic framework, “EU-compliant” is not a single checklist — it is the Directive’s shared rules plus whichever national rules apply in your first market.
National notification before sale
Most EU member states still require the company placing a food supplement on their market to notify the national competent authority, typically by submitting a copy of the label, before or when the product goes on sale.
| Element | How it typically works |
|---|---|
| Legal basis | Directive 2002/46/EC allows (but does not require) member states to ask for this notification |
| What is usually submitted | A copy of the label used on the market, sometimes with composition details |
| Where it applies | The great majority of member states use some form of notification; a small number, including the UK before it left the EU system, do not require it |
| Effect | Notification is generally not a pre-market authorisation — the product does not wait for approval — but it is a legal condition of sale in that country |
Because notification is organised nationally, a formula cleared for sale in one member state is not automatically notified anywhere else — each country you sell into needs its own notification, in its own language, from whichever company is legally placing the product on that market.
💬 Selling into more than one EU country? Tell us your target markets so we can flag what each one is likely to ask for.
Novel Food status
An ingredient that was not used for human consumption to a significant degree in the EU before 15 May 1997 is a “novel food” under Regulation (EU) 2015/2283, and cannot be sold in the EU until it is authorised.
| Step | What it means |
|---|---|
| Trigger date | Significant consumption history in the EU before 15 May 1997 is the test |
| Where to check | The EU Novel Food Catalogue gives an overview of ingredients’ status, though it mainly documents botanicals and is not a complete legal register on its own |
| If novel | The ingredient needs authorisation added to the EU’s Union list of authorised novel foods before it can be used, via a dossier assessed by EFSA |
| Relevance to Japanese formulas | Some ingredients common in Japanese supplements (certain algae, insect or fermentation-derived ingredients, or specific extracts) may have no established history of consumption in the EU and need checking individually |
This check matters early — a novel food authorisation is a Union-wide process assessed by EFSA, not a national filing, and is not something a single member state can waive.
Health claims and the EU Register
A health claim on an EU label must be one of the claims authorised in the EU Register of nutrition and health claims, used in its approved wording, and meeting its stated conditions of use.
| Element | Requirement |
|---|---|
| Legal basis | Regulation (EC) No 1924/2006, applying since 1 July 2007, and the list in Commission Regulation (EU) No 432/2012 and later updates |
| What is allowed | Only claims listed in the EU Register, in essentially the approved wording, and only when the product meets the claim’s stated conditions (for example, a minimum nutrient level per serving) |
| What is not allowed | Any health claim not on the Register, and claims that imply disease prevention or cure outside the authorised medical-food or specific-claim frameworks |
| How new claims are added | A business submits a dossier via a member state to EFSA, which gives a scientific opinion, before the Commission decides |
A function statement used freely on a Japanese label — describing everyday benefits under Japan’s own Foods with Function Claims system — cannot be carried over to an EU label; it has to be matched to an authorised EU claim or left off.
Labelling language and maximum nutrient levels
An EU food supplement label must be provided in a language easily understood in the member state where it is sold, and maximum vitamin and mineral levels are set by each member state rather than harmonised EU-wide.
| Element | Where the rule sits |
|---|---|
| Label language | National — generally the official language(s) of the member state of sale, sometimes more than one |
| Maximum levels of vitamins/minerals | Set nationally; the EU has not adopted harmonised maximum and minimum levels for Annex I nutrients despite discussion at EU level |
| Mandatory food-supplement wording | Directive 2002/46/EC requires the product to be labelled with the term “food supplement” (or the national equivalent) and standard food-information requirements alongside it |
| Practical effect | A label built for one member state’s language and permitted maximum levels usually needs review, not just translation, before it is used in another |
Before you ask for a quotation
- Your first EU market(s) and whether each requires national notification
- Whether every ingredient in the formula has an established EU consumption history, or needs a Novel Food check
- Any health claim you intend to make, matched against the EU Register’s authorised wording
- Label language(s) and the nutrient maximums that apply in your first market
- Documents to request from the factory: specification sheet, Certificate of Analysis, Certificate of Free Sale
💬 Ready to plan an EU-bound Japan-made supplement? Send us your target countries and formula and we will flag what needs checking first.
Frequently asked questions
1. Does Directive 2002/46/EC mean my supplement is automatically approved across the whole EU?
No. The Directive harmonises the basic definition and the permitted vitamin/mineral list, but notification, label language, and maximum nutrient levels are still decided country by country.
2. Do I need pre-market approval to sell a food supplement in the EU?
Generally no, unless an ingredient is a novel food requiring Union-level authorisation. Most member states use notification, not pre-approval, for an otherwise compliant formula.
3. How do I know if my ingredient is a “novel food”?
Check whether it has a significant history of consumption in the EU before 15 May 1997. The EU Novel Food Catalogue is a useful starting reference but does not cover every ingredient, so an unclear case should be checked individually.
4. Can I use the same health claim wording as a Japanese Foods with Function Claims product?
No. An EU health claim has to come from the authorised wording in the EU Register under Regulation (EC) No 1924/2006; Japanese claim wording is not transferable.
5. Why do maximum vitamin and mineral levels differ between EU countries?
Because the EU has not set harmonised maximum and minimum levels for vitamins and minerals in food supplements at Union level, so each member state applies its own.
Sources: Directive 2002/46/EC of the European Parliament and of the Council, eur-lex.europa.eu; European Commission, “Food supplements,” food.ec.europa.eu; Regulation (EU) 2015/2283 on novel foods, eur-lex.europa.eu; European Commission Novel Food Catalogue guidance; Regulation (EC) No 1924/2006 on nutrition and health claims and Commission Regulation (EU) No 432/2012, eur-lex.europa.eu; European Commission, “Nutrition and Health Claims,” food.ec.europa.eu. Checked on 25 September 2026.