Food Supplements - keytoxicology


Food Supplement

Food supplements are defined as foodstuff which are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect. They are marketed in “dose” form (e.g. pills, tablets, capsules, liquids in measured doses) to be included in the normal diet. The European Union (EU) regulates Food Supplements through the Directive 2002/46/EC.
However, they are considered foodstuff and therefore several additional European legislations will apply, on top of specific national laws. Due to the complexity of the applicable legislative frameworks, guidance of professional regulatory advice is critical. All UK food supplements have been regulated under UK law through the Food Safety Act.It is the responsibility of the manufacturer, importer or distributor to comply with all of the relevant legislation.
Legislation which covers food supplements includes:
  • Food Safety Act 1990
  • EC Food Supplements Directive (Directive 2002/46/EC) and amendments which can be found on the Commission website
  • The Food Supplements Regulations implement the Directive into UK law.
    • 12 legislations can be found at
  • Food Information for Consumers Regulation 1169/2011
  • Nutrition and Health Claims Regulation (EC/1924/2006)
The Food Information for Consumers Regulation regulates labelling requirements and other information which must be made available to consumers at point of purchase. It applies to all foods, including food supplements. The UK government enforce strict labelling and packaging requirements to be presented on all products made or sold within the UK.
We will check the formula of your products, identifying restricted and banned ingredients at both a United Kingdom / European and national level, prepare & submit the product information file.
  1. We will assess the necessary / available documentation for your type of product
  2. We will review and propose strategies to compile a complete Food Supplement Information File
  3. We will check and provide the compliance of your labels and packaging towards the UK / EU and national requirements
  4. We will submit the pre-market authorization at a national level
  5. Handle the request for further information (RFi) and provide response
  6. To get Approval of Food supplement
  7. To assist in implementation of approved product information file during each supply
We Are a member of the three bodies
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