1. Legal Definition of Food Supplements (Directive 2002/46/EC)
According to Article 2(a) of Directive 2002/46/EC, food supplements are:
Concentrated sources of nutrients (e.g., vitamins, minerals) or other substances with nutritional and physiological effect.
Marketed in small, measured doses (e.g., pills, powders, ampoules).
2. Marketing & Labeling Restrictions
- No Medicinal Claims Allowed – Food supplements cannot be marketed as preventing, treating, or curing diseases (Article 6(2) of Directive 2002/46/EC).
- Health & Nutrition Claims Must Follow EU Law – Only permitted claims listed in the EU Register of Nutrition & Health Claims can be used.
- Accurate Labeling Required – Labels must include nutrient composition, nature of the nutrients or substances, dosage instructions, and safety warnings.
3. Approved Nutrients & Sources in Food Supplements according to Directive 2002/46/EC
Annex I – Lists the vitamins and minerals that can be included in food supplements.
Annex II – Specifies the approved chemical forms of vitamins and minerals that can be used in food supplements.
4. Key Requirements for Food Supplement Manufacturers
- Compliance with Good Manufacturing Practices (GMP) – Ensures product quality and safety.
- EU labelling and advertising requirements – Ensures protection of consumers and facilitate their choice for safe products (Directive 2002/46/EC)
- Registration with National Authorities – Some EU countries require notification before market entry.
Why Food Supplement Regulations Matter
- Protects Consumers from Misleading Claims – Ensures scientific accuracy in marketing.
- Prevents Unregulated Products from Entering the Market – Guarantees product safety and compliance.
- Harmonizes Food Supplement Regulations Across the EU – Facilitates cross-border trade and consumer protection.