Gummy supplements in the EU must meet strict labeling requirements. The primary regulation is the EU Food Information to Consumers (FIC) Regulation, since gummies are classified as food supplements. Get the label right and your product is safe, properly described, and legal across member states.
Core Regulatory Framework
The primary legislation is Regulation (EU) No 1169/2011 on the provision of food information to consumers (FIC Regulation). It's supplemented by Directive 2002/46/EC on food supplements, which sets specific rules for vitamins, minerals, and other substances. And the Nutrition and Health Claims Regulation (EC) No 1924/2006 governs any statements about a product's benefits.
Mandatory Labeling Information
Every label must include the following information in the local language of the country of sale:
- Name of the Food: The legal name "food supplement" plus a description of its nature (e.g., "Vitamin D gummy supplement").
- List of Ingredients: Complete list in descending order by weight: active ingredients, gelling agents, sweeteners, colors, flavors. Allergens must be emphasized (e.g., bold).
- Net Quantity: The weight or volume of the gummies.
- Recommended Daily Dosage: Clear instructions with a warning not to exceed the dose, plus a statement that supplements should not be used as a substitute for a varied diet.
- Nutrition Declaration: The "Big 7" per 100g or per portion: energy, fat, saturates, carbohydrate, sugars, protein, salt. For supplements, typically shown per daily dose.
- Nutrient amounts: Amounts of each active substance per daily portion, in numbers; vitamins and minerals are also given as a percentage of the Nutrient Reference Value (NRV).
- Storage Conditions & Expiry Date: Use "Best before..." plus date.
- Business Name & Address: Name and address of the responsible food business operator.
- Country of Origin: Required if omission would mislead.
- Instructions for Use: For safe and effective consumption.
Mandatory particulars must be legible. Under the FIC Regulation, the minimum font size is an x-height of 1.2 mm, falling to 0.9 mm on packages with a largest surface area below 80 cm².
Critical Prohibitions and Considerations
- No Medical Claims: Labels must not imply treatment or cure. Health claims must be pre-approved and on the EU Register.
- Clear Distinction from Medicine: The presentation must not confuse the gummy with a medicinal product.
- Child Safety: Candy-like appearance makes warnings like "Keep out of reach of young children" essential.
- Novel Foods: Non-traditional ingredients need pre-market authorization under Regulation (EU) 2015/2283.
- Maximum doses: EU-wide maximum levels for vitamins and minerals are not yet harmonized, so the daily dose you declare must respect the national limits that apply in each member state where you sell.
Final Steps Before Market Entry
Before launch, consult a regulatory expert. Where the member state requires it, notify the competent authority in the first member state where you place the product and provide a model label. Keep up with regulatory changes. Compliance is an ongoing process.