Putting gummy supplements on the EU market? The labeling rules are clear and mandatory. They're set by the European Food Safety Authority (EFSA), which classifies gummies as food supplements—not medicines. And compliance isn't optional; it's the price of entry.
Core Regulatory Framework
A handful of EU regulations govern gummy supplement labels. Here are the main ones:
- Regulation (EU) No 1169/2011 (FIC): The main food labeling rule, covering all supplements.
- Directive 2002/46/EC on food supplements: Sets rules for vitamins, minerals, and other ingredients.
- Regulation (EC) No 1924/2006 on nutrition and health claims: Strictly controls what claims you can make.
- Regulation (EU) No 609/2013 on food for specific groups: Reinforces general labeling principles.
Mandatory Labeling Information
The FIC Regulation and Food Supplements Directive spell out exactly what must appear on your label:
- Name of the product: The legal name "food supplement" must appear.
- List of ingredients in descending order by weight, including actives (vitamins, minerals, botanicals) and excipients (gelling agents, colors, flavors).
- Net quantity (e.g., 60 gummies).
- Recommended daily dosage—with a clear instruction not to exceed it.
- Nutrition declaration: Amounts of vitamins, minerals, and other active substances, expressed as a percentage of the Nutrient Reference Value (NRV) where applicable.
- Storage conditions or conditions of use, if special.
- Name and address of the responsible food business operator (manufacturer, importer, or seller).
- Country of origin, if omitting it would mislead consumers.
- Warning statements if the product contains ingredients like caffeine or licorice root that may be of concern in certain amounts.
- The statements: "Food supplements should not be used as a substitute for a varied diet." and "Keep out of reach of young children."
Critical Considerations for Claims
Regulation (EC) No 1924/2006 requires that any nutrition or health claim be pre-approved and listed on the EU's authorized claims register. Only scientifically substantiated and authorized claims are allowed. And you can't claim a supplement can prevent, treat, or cure a disease.
Additional Requirements
Labels must be legible, permanent, and in the language of the member state where the product is sold. If your gummies contain novel foods or botanicals, extra authorizations and labeling rules apply. Working with a regulatory expert or lawyer is wise—non-compliance can lead to recalls, fines, or being pulled from the market.