EU Supplement Labeling Requirements: Vitamins, Minerals & Botanicals

A US supplement brand’s first encounter with EU labeling requirements typically produces the same reaction: the US Supplement Facts panel they’ve used for years doesn’t translate directly to EU requirements, and the health claims they use routinely in the US are either prohibited or require specific wording in the EU. Getting EU supplement labels right requires understanding two overlapping regulatory frameworks — and the national variations that add complexity on top.

The Two Regulatory Frameworks for EU Supplement Labels

EU food supplement labels must comply with two primary regulations:

Regulation (EU) No 1169/2011 on food information to consumers: The general food labeling regulation that applies to all food products sold in the EU, including food supplements. It sets out mandatory particulars that must appear on all food labels.

EU Directive 2002/46/EC on food supplements: The supplement-specific directive that adds requirements specific to food supplements, including mandatory warnings and the requirement to express nutrients as a percentage of Nutrient Reference Values (NRVs).

Mandatory Label Information Under EU Law

The following information must appear on EU food supplement labels:

1. Product Name

The product name must include the term “food supplement” (or the equivalent in the language of the member state where the product is sold). This is a mandatory designation under Directive 2002/46/EC.

Examples:

• “Vitamin C Food Supplement” (UK/Ireland)
• “Complément alimentaire à base de vitamine C” (France)
• “Nahrungsergänzungsmittel mit Vitamin C” (Germany)

2. Names of the Categories of Nutrients or Substances

The label must identify the categories of nutrients or substances that characterise the product. For a multi-vitamin supplement, this means listing the vitamins and minerals it contains. For a botanical supplement, this means identifying the botanical ingredient.

3. Serving Size and Recommended Daily Dose

The label must state the recommended daily dose (serving size) in a clear, unambiguous way. This is typically expressed as “Take X capsules per day” or “X ml per day.”

4. Warning: Do Not Exceed Recommended Daily Dose

Mandatory warning under Directive 2002/46/EC: “Do not exceed the recommended daily dose.”

This warning must appear on all EU food supplement labels. It is not optional and cannot be replaced with softer language.

5. Warning: Food Supplements Should Not Replace a Varied Diet

Mandatory statement: “Food supplements should not be used as a substitute for a varied and balanced diet and a healthy lifestyle.”

The exact wording may vary slightly between member states’ national implementations, but the substance of the statement is mandatory.

6. Warning: Keep Out of Reach of Young Children

Mandatory statement: “Keep out of the reach of young children.”

7. Nutrient Reference Values (NRVs)

For vitamins and minerals, the label must state the amount per serving as a percentage of the Nutrient Reference Value (NRV). NRVs are set out in Regulation (EU) No 1169/2011, Annex XIII.

NRVs replace the US Daily Values (DVs) concept. The values are similar but not identical:

Nutrient	EU NRV	US Daily Value
Vitamin C	80 mg	90 mg
Vitamin D	5 μg (200 IU)	20 μg (800 IU)
Calcium	800 mg	1,300 mg
Iron	14 mg	18 mg
Magnesium	375 mg	420 mg
Zinc	10 mg	11 mg

The NRV for Vitamin D is notably lower in the EU (5 μg) than in the US (20 μg), which means a 1,000 IU Vitamin D supplement represents 500% of the EU NRV but only 125% of the US DV.

8. Net Quantity

The net quantity must be stated in metric units — grams (g), millilitres (ml), or number of units (e.g., “60 capsules”). The net quantity must be expressed in a way that allows the consumer to understand the total amount of product in the package.

9. Best Before Date or Minimum Durability

The date of minimum durability (“best before” date) must appear on the label in the format “Best before: DD/MM/YYYY” or “Best before end: MM/YYYY.” For supplements with a shelf life of more than 3 months, the day may be omitted.

10. Storage Conditions

If the product requires specific storage conditions (e.g., “Store in a cool, dry place,” “Store below 25°C”), these must be stated on the label.

11. Name and Address of the Responsible Party

The name and address of the manufacturer, packer, or EU-established seller must appear on the label. For non-EU manufacturers, this is typically the EU importer or Responsible Person.

12. Country of Origin (Where Required)

For products manufactured outside the EU, the country of origin must be stated where its omission might mislead the consumer.

13. Lot Number

A lot number (batch number) must appear on the label for traceability purposes.

14. Language Requirements

Labels must be in the official language(s) of the member state where the product is sold. A supplement sold in France must have a French label. A supplement sold in Germany must have a German label. Multi-language labels are permitted as long as all required information is present in the relevant language.

Health Claims: What You Can and Cannot Say

Only health claims authorised under Regulation (EC) No 1924/2006 may be used on EU supplement labels. The EU Register of authorised health claims contains approximately 250 approved claims, primarily for vitamins and minerals.

Examples of authorised claims:

• “Vitamin C contributes to the normal function of the immune system”
• “Calcium is needed for the maintenance of normal bones”
• “Iron contributes to normal cognitive function”
• “Magnesium contributes to the reduction of tiredness and fatigue”

Claims that are NOT permitted in the EU (but are common in US supplement marketing):

• “Boosts immunity” (not an authorised claim)
• “Supports brain health” (not an authorised claim — specific authorised wording must be used)
• “Promotes energy” (not an authorised claim — “contributes to normal energy-yielding metabolism” is authorised for specific nutrients)
• Any disease claim (“prevents cancer,” “reduces risk of heart disease”) — these require specific Article 14 authorisation

French-Specific Labeling Requirements

France has additional national labeling requirements for food supplements:

DGCCRF notification: Before marketing, a notification must be submitted to DGCCRF. The label used in the notification must match the label on the product.

Specific warnings for certain ingredients: DGCCRF has published guidance on additional warnings required for supplements containing certain botanical ingredients, high-dose vitamins, or ingredients with specific safety concerns.

French language: All mandatory label information must be in French. Optional information may be in other languages provided the French information is equally prominent.

Common EU Labeling Mistakes Made by US Brands

1. Using “Supplement Facts” panel format: EU labels do not use the Supplement Facts format. Nutrition information must be presented in the EU nutrition declaration format.

2. Using US Daily Values instead of EU NRVs: The percentages will be wrong if US DVs are used instead of EU NRVs.

3. Missing mandatory warnings: The three mandatory warnings (do not exceed recommended dose, not a substitute for varied diet, keep out of reach of children) are frequently omitted by US brands.

4. Using unauthorised health claims: Structure/function claims that are standard in the US are often not authorised in the EU.

5. Missing “food supplement” designation: The product name must include “food supplement” (or national equivalent).

6. Not translating into local languages: A single English label cannot be used across all EU markets.

At Care Europe, we develop EU-compliant supplement labels for brands entering the EU market, including NRV calculations, authorised claims review, and country-specific language adaptations. Contact us at [email protected].