EU DIETARY SUPPLEMENTS, REGULATORY COMPLIANCE CORE COMPETENCIES & EXPERIENCE

 

ST&T's European Office Located in Brussels, Belgium (approximately 2 blocks from European Commission) brings together expertise in Safety and Regulatory & Government Affairs Expertise / Borderline Products with expert international staff covering 10 major languages.

ST&T's Specific EU Dietary Supplement Experience:

Review of dietary supplements and their ingredients to make sure they comply with the Food Supplements Directive (2002/46/EC) and any local member state regulations

  •  Labeling and packaging review for compliance with the Food Labeling Directive (2000/13/EC) and any local member state regulations.
  •  Claims review to verify that claims used in labeling and marketing materials are not related to disease treatment or prevention that would qualify them as a drug
  •  Assistance with Nutrition and Health claim approval in the EU based on evaluation against the Nutrition and Health Claims Regulation (No 1924/2006). This includes filing for the protection of scientific evidence, obtaining positive opinion from the European Food Safety Authority and submission of application dossier to the European Commission for the authorization of Health Claims or Reduction of Disease Risk Claims
  •  Experience with all 4 Main Claims procedures resulting from the Nutrition & Health Claims Regulation:
    • Nutrition Claims (NC)
    • Health Claims (HC)
    • Reduction of Disease Risk Claims (RDRC)
    • Claims on Children Development & Health (CDHC)
  •  Evaluation of borderline products and recommendation on whether a product is a food, food supplement or medicinal products