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Regulation

Food Supplement (2002/46/EC): EU nutrition label

Food Supplement (2002/46/EC), the EU nutrition label under Directive 2002/46/EC; Regulation (EU) No 1169/2011 Annex XIII. Generate a compliant label free.

Reviewed against Directive 2002/46/EC; Regulation (EU) No 1169/2011 Annex XIII · Page updated October 25, 2026

Jurisdiction
European Union (packaged food sold at retail)
Regulation
Directive 2002/46/EC; Regulation (EU) No 1169/2011 Annex XIII
Effective
12 July 2002
Official source
eur-lex.europa.eu
Generate the EU labelEU 1169/2011 guide

Nutrition labelling requirements in the EU

Packaged food sold in the EU must carry a nutrition declaration under Directive 2002/46/EC; Regulation (EU) No 1169/2011 Annex XIII. This page covers the EU - Food Supplement (2002/46/EC) format: Per daily dose with % NRV - Directive 2002/46/EC, Reg. 1169/2011 Annex XIII. A supplement panel lists whatever the product contains rather than a fixed set, but 27 nutrients have a published reference intake, values are declared per daily dose and alongside a % NRV* column. The panel carries the footnote "* NRV = Nutrient Reference Value (Regulation (EU) No 1169/2011).". The panel is headed "Food Supplement". NutritionFactLabel builds a print-ready EU nutrition label from your recipe, applying the rounding rules and reference intakes for the EU automatically, and exports it as PDF, PNG, SVG, JPG or EPS.

Official regulation

Citation
Directive 2002/46/EC; Regulation (EU) No 1169/2011 Annex XIII
Effective
12 July 2002
Scope
European Union (packaged food sold at retail)
Source

Key facts

Panel heading
Food Supplement
Reference values defined
27 nutrients with a published reference intake
Column caption
Per daily dose
Percentage column
% NRV*
Required footnote
* NRV = Nutrient Reference Value (Regulation (EU) No 1169/2011).

EU food supplement labelling requirements under Directive 2002/46/EC

Directive 2002/46/EC, in force, sets the EU's specific labelling rules for food supplements. The product must be sold under the name "food supplement", which is mandatory, and the label must name the categories of nutrients or substances that characterise it, or indicate their nature.

The label must also carry these mandatory particulars:

  • 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 the reach of young children.

Labelling, presentation and advertising must not claim that the supplement prevents, treats or cures human disease, and must not state or imply that a balanced and varied diet cannot provide enough nutrients. The general food information rules of Regulation (EU) No 1169/2011 apply alongside these supplement rules.

Source: Directive 2002/46/EC, Articles 6 and 7, EUR-Lex.

Nutrient declaration per daily dose and % NRV

EU supplements do not use the standard nutrition declaration table for ordinary foods. Article 29 of Regulation (EU) No 1169/2011 excludes products covered by Directive 2002/46/EC from that section, and Article 8 of the Directive sets a supplement-specific declaration instead, which is mandatory.

The amounts of nutrients and other substances with a nutritional or physiological effect must be declared numerically, per portion recommended for daily consumption, as average values based on the manufacturer's analysis. Vitamins and minerals must also be given as a percentage of the nutrient reference values (NRVs) now set in Annex XIII, Part A of Regulation (EU) No 1169/2011, for example 80 mg for vitamin C and 800 mg for calcium.

Showing the % NRV in graphic form is voluntary. The per-daily-dose basis is the key difference from US Supplement Facts, which declare per serving.

Source: Directive 2002/46/EC, Articles 8 and 9, and Regulation (EU) No 1169/2011, Article 29 and Annex XIII, EUR-Lex.

Health claims on EU supplement labels

Nutrition and health claims on food supplements are governed by Regulation (EC) No 1924/2006, in force. A health claim may only be used if it is authorised and listed in the EU register, and the claim's conditions of use are mandatory. Commission Regulation (EU) No 432/2012 holds the Union list of many authorised function claims and their conditions.

Using a health claim triggers mandatory accompanying information, including a statement on the importance of a varied and balanced diet and a healthy lifestyle, and the quantity and pattern of consumption needed for the claimed effect. Where relevant, statements for people who should avoid the product and warnings about excessive consumption are also required.

Disease prevention, treatment or cure claims stay prohibited for food supplements. An authorised health claim describes an approved link between a nutrient or substance and a body function, not a medical effect.

Source: Regulation (EC) No 1924/2006 and Commission Regulation (EU) No 432/2012, EUR-Lex.

Importing supplements into the EU: language, responsibility and notification

Mandatory food information must appear in a language easily understood by consumers in the Member State where the product is sold, under Regulation (EU) No 1169/2011. A Member State may require one or more of its official EU languages on its territory, and multilingual labels are permitted.

If the brand owner is not established in the EU, the importer is the food business operator responsible for the food information, which is mandatory. In practice this means a product imported from outside the EU often needs a new label: the "food supplement" name, the daily-dose basis, the four required statements, % NRV values, claims limited to authorised wording, and the right languages.

The Directive is applied through national law, so national competent authorities enforce it. Member States may require notification when a supplement is placed on their market, including a model of the label. The European Commission manages the EU framework, and EFSA provides the scientific assessment behind health claims.

Source: Directive 2002/46/EC, Articles 10, 14 and 15, Regulation (EU) No 1169/2011, Articles 8 and 15, and European Commission, Food supplements.

How NutritionFactLabel handles it

  • Applies the correct rounding rules for every nutrient
  • Uses the right Daily Value / Reference Intake table for this jurisdiction
  • Renders the required front-of-pack warnings automatically when thresholds are hit
  • Handles multilingual labels where required (bilingual EN/FR, EN/ES, Arabic + EN, etc.)
  • Exports print-ready vector PDF, PNG, SVG, JPG, and EPS

Common questions

What must a food supplement label show in the EU?
The name "food supplement", the characterising nutrients or substances, the recommended daily portion, a warning not to exceed it, a varied-diet statement and a keep-out-of-reach-of-children statement. These are mandatory under Directive 2002/46/EC, on top of the general rules in Regulation (EU) No 1169/2011.
How are vitamins and minerals declared on an EU supplement label?
Numerically, per daily portion, and as a percentage of the NRVs in Annex XIII of Regulation (EU) No 1169/2011. For example, the NRV for vitamin C is 80 mg.
Does an EU food supplement need the standard nutrition declaration?
No. Article 29 of Regulation (EU) No 1169/2011 excludes food supplements from that section. They use the supplement-specific declaration in Article 8 of Directive 2002/46/EC instead.
Who regulates food supplements in the EU?
National competent authorities enforce the rules, since the Directive is applied through national law. The European Commission manages the EU framework and EFSA assesses health claims.
Are health claims allowed on EU supplement labels?
Only authorised claims under Regulation (EC) No 1924/2006, used under their conditions of use, with the required accompanying statements. Disease prevention, treatment or cure claims are prohibited.
What does an importer need to change before selling a supplement in the EU?
Usually the name, the daily-dose declaration with % NRV, the four mandatory statements, any claims and the label language. The EU importer is responsible for the food information if the brand owner is outside the EU, and some Member States require notification first.

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