Dietary supplements: labelling and mandatory mentions

Dietary supplements are foodstuffs governed by Directive 2002/46/EC and subject to FIC Regulation 1169/2011 for labelling. Their positioning between food and health makes labelling particularly sensitive: controlled claims, prohibition of therapeutic properties, mandatory warnings. This guide details each requirement for the European market.

1. Regulatory framework

Dietary supplement labelling rests on three regulatory pillars:

• Directive 2002/46/EC — Harmonises rules on dietary supplements in the EU: definition, positive list of authorised vitamins and minerals, admissible chemical forms
• Regulation (EU) 1169/2011 (FIC) — General food labelling rules applicable to supplements as to any food
• Regulation (EC) 1924/2006 — Governs nutrition and health claims usable on labels and advertising

In France, Decree 2006-352 transposes the directive and adds national requirements (DGCCRF declaration via Teleicare before marketing).

2. Mandatory denomination

The denomination "food supplement" (or "dietary supplement") must appear on the label. This denomination is regulated and cannot be replaced by terms like "nutraceutical" or "functional food".

3. Mandatory label mentions

In addition to standard FIC mentions (operator, batch, BBD, etc.), a dietary supplement label must bear:

• "Food supplement" denomination
• Ingredients list — In descending order by weight, allergens highlighted (Art. 21 FIC)
• Nutrient/substance quantities — Per recommended daily dose, in mg or mcg, also expressed as % of Nutrient Reference Values (%NRV) where available
• Recommended daily dose — Clearly stated (e.g. "2 capsules per day")
• "Do not exceed the recommended daily dose" warning
• "Does not replace a varied and balanced diet" warning
• "Keep out of reach of young children" warning
• Storage conditions — If necessary
• Net quantity — Number of capsules/tablets or net weight

4. Health claims — Regulation (EC) 1924/2006

Health claims are strictly regulated. Only authorised claims listed in the EFSA register may be used. Three categories:

• Functional health claims (Art. 13.1) — Role of a nutrient in body functions (e.g. "Vitamin C contributes to the normal function of the immune system"). Positive list in Reg. (EU) 432/2012.
• Claims based on new evidence (Art. 13.5) — New claims requiring prior EFSA authorisation.
• Disease risk reduction claims (Art. 14) — Case-by-case authorisation.

Therapeutic claims ("cures", "treats", "prevents a disease") are absolutely prohibited on a dietary supplement.

5. Mandatory warnings

Beyond the three standard warnings (dose, diet, children), specific warnings are required for certain substances:

• Caffeine — "High caffeine content. Not recommended for children or pregnant or breastfeeding women" (if > 150 mg/L or > 75 mg per serving)
• Polyols — "Excessive consumption may have laxative effects"
• Phytosterols — "Patients on cholesterol-lowering medication should consume the product only under medical supervision"
• Iron (high doses) — Overdose warning recommended in some Member States

6. Novel Food — Regulation (EU) 2015/2283

Any ingredient not significantly consumed in the EU before 15 May 1997 is considered "novel food" and requires prior Commission authorisation after EFSA evaluation.

Examples: krill oil, synthetic astaxanthin, chia seeds (for certain uses), insect proteins, CBD (variable status by Member State).

7. Common mistakes

• Unauthorised health claims (e.g. "boosts immunity" without EFSA register reference)
• Therapeutic properties on label ("anti-inflammatory", "fights diabetes")
• Missing Nutrient Reference Value (%NRV) percentages
• "Organic" mention without certified organic body
• Missing three mandatory warnings (dose, diet, children)
• Unauthorised novel food ingredient
• Daily dose unspecified or ambiguous
• Active substance quantities per box instead of per daily dose

Frequently asked questions

Can you use the claim "boosts immunity" on a dietary supplement?

Not in that exact wording. Authorised claims are listed in the EFSA register (Reg. 432/2012). For example, "Vitamin C contributes to the normal function of the immune system" is authorised, but "boosts immunity" is a non-approved wording that may be considered misleading.

What are the labelling differences between a dietary supplement and a medicine?

A dietary supplement is a foodstuff (Directive 2002/46/EC): it cannot claim any therapeutic property. A medicine (Directive 2001/83/EC) may mention therapeutic indications but requires marketing authorisation. If a supplement label mentions prevention or treatment of a disease, the product is reclassified as a medicine by presentation.

Must a dietary supplement display an ingredients list like a food product?

Yes. Dietary supplements are foodstuffs under FIC Regulation 1169/2011. They must display an ingredients list in descending order by weight, with allergens highlighted. Additionally, nutrient and active substance quantities must be indicated per recommended daily dose.