Food Supplements Directive Readiness (EU 2002/46/EC)
Use only listed vitamins and minerals and forms, print every mandatory statement and keep disease claims off the pack.
In Short
- Name it food supplement.
- Five label statements required.
- No prevent, treat or cure claims.
The Dietary Supplement Operations Guide
What the label says. What the batch proves.
- The rules and who decides
- Specification to finished batch
- Test, review, investigate
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
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The Dietary Supplement Operations Guide
What the label says. What the batch proves.
Directive 2002/46/EC sets EU-wide rules for food supplements: what they are, which vitamins and minerals and forms may be used, and what the label must say. As a directive, it works through national law, and Member States may require notification of the label. This guide follows the consolidated text of 30 September 2022. National rules, other substances and claims law are outside it. Orientation, not legal advice. Sources checked 4 Oct 2026.
What counts as a food supplement
Article 2(a) defines food supplements as foodstuffs intended to supplement the normal diet that are concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form such as capsules, tablets, pills, sachets of powder, ampoules and drop dispensing bottles. Article 1 limits the directive to products marketed as foodstuffs and presented as such, sold to the consumer only prepacked, and excludes medicinal products under Directive 2001/83/EC.
More on what counts as a food supplement
Borderline products need a separate medicinal-product assessment, which this guide does not cover.
Permitted Vitamins, Minerals and Forms
Article 4(1) allows only vitamins and minerals listed in Annex I, in the forms listed in Annex II. Purity criteria apply as set out in Article 4(2) to (4).
More on permitted Vitamins, Minerals and Forms
Article 5 provides for maximum and minimum amounts per recommended daily portion, set with regard to upper safe levels and intake from other sources. The annexes and any harmonised amounts were not reproduced here; check the current consolidated annexes and national maximum levels before approving a formula. Other substances, such as botanicals, follow national law and, where relevant, novel food rules.
Mandatory Label Particulars
Article 6(1) requires the name food supplement. Article 6(3) requires the categories of nutrients or substances that characterise the product, the portion recommended for daily consumption, a warning not to exceed the stated recommended daily dose, a statement that food supplements should not be used as a substitute for a varied diet, and a statement that the product should be stored out of reach of young children.
Mandatory label particulars (Article 6)
More on mandatory Label Particulars
Article 8 requires the amount of each nutrient or substance declared numerically per recommended daily portion, with vitamins and minerals also given as a percentage of reference values.
Claims you must not make
Article 6(2) bars labelling, presentation and advertising from attributing to a food supplement the property of preventing, treating or curing a human disease, or referring to such properties. Article 7 bars any statement that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.
More on claims you must not make
Nutrition and health claims are also governed by separate EU rules that were not opened for this guide. Have a qualified reviewer check every label, leaflet and web page against these articles and the claims rules before release.
Declared Values and National Notification
Article 9 says declared values are averages based on the manufacturer's analysis of the product. That ties label figures to analytical evidence and stability data for the shelf life.
Worked Example: Product FS-VD3 Country Register
| Country | Notification | Label version |
|---|---|---|
| Country A | Filed with model label, dated | v4 |
| Country B | Not required (checked, dated) | v4 |
| Country C | Pending reviewer sign-off | v5 draft |
- Country A
- Notification
- Filed with model label, dated
- Label version
- v4
- Country B
- Notification
- Not required (checked, dated)
- Label version
- v4
- Country C
- Notification
- Pending reviewer sign-off
- Label version
- v5 draft
More on declared Values and National Notification
Article 10 lets Member States require the manufacturer or the person placing the product on the market in their territory to notify the competent authority by sending a model of the label. Requirements and portals differ by country, so keep a per-country register of notifications, label versions and dates. People approve formulas and labels; records only show what was approved.
Questions
Which label statements are mandatory?
Article 6(3): characterising nutrient or substance categories, recommended daily portion, do-not-exceed warning, not a substitute for a varied diet, and keep out of reach of young children. The name must be food supplement (Article 6(1)).
Can a supplement label mention a disease?
No. Article 6(2) bars attributing the property of preventing, treating or curing a human disease, or referring to such properties.
Are botanicals covered by the directive's positive lists?
No. Article 4(1) lists vitamins and minerals only. Other substances follow national rules and, where relevant, other EU law such as novel food rules.
Do we have to notify each country?
Possibly. Article 10 allows Member States to require notification with a model label. Check each country where you place the product.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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