Xavi&Rea Solutions


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  • Assessors of Technical Documentation
  • Our Tasks
  • Notified Body
  • Our Scope
    • Medical Devices
    • In Vitro Diagnostic Medical Devices
    • Food Supplements
    • Cosmetics (including Make-up)
    • Fragrances and Essential Oils
    • Candles
    • Detergents
    • Chemical Mixtures
  • EU Representative
  • Import & Export Agents

Food Supplements


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3. Food Supplements



Definition:
Food Supplements are concentrated sources of nutrients or other substances (e.g., vitamins, minerals, botanicals) intended to supplement the diet, typically sold in forms like capsules, tablets, or powders.





EU Regulations:

  • Directive 2002/46/EC (Food Supplements Directive): Establishes harmonized rules for labeling, composition, and safety of food supplements.
  • Regulation (EC) No 1924/2006 (Nutrition and Health Claims): Regulates claims made on food supplements to ensure they are scientifically substantiated.
  • Regulation (EU) No 1169/2011 (Food Information to Consumers): Governs labeling requirements, including allergen information and nutritional content.
  • Key Requirements: Notification to national authorities, maximum safe levels for vitamins/minerals, accurate labeling, and compliance with health claim rules.
  • Our Role: We provide compliance support, including dossier preparation, labeling reviews, and regulatory guidance to ensure market readiness.


Xavi&Rea Solutions



Company Registration Number: C 112273
SOHO St. Julians Punchbowl Centre, Elia Zammit Street
ST. JULIANS STJ 3154 MALTA