EU Regulations for Functional Foods from Botanical Sources

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EU Regulations

EU Regulations for Functional Foods from Botanical Sources

Fortified and functional foods derived from botanical sources are classified as novel foods in the EU. Before being authorised, they must pass a stringent safety evaluation by the European Food Safety Authority (EFSA). 

  •  This assessment includes evaluating the potential health benefits and risks associated with fortified food and functional food and its nutritional properties, toxicological profile, and production methods.  
  • Fortified and functional food products from botanical sources must comply with EU regulations for food labelling and health claims. Specifically, health claims for botanicals must be substantiated by scientific evidence. Additionally, the description of the food, product composition and its source must be given. 
  • In addition, the botanical ingredients must have a history of safe use in food or have undergone safety evaluation as a novel food. The evaluation has been centralised since 2018, and centralised testing ensures harmonisation throughout the EU. 
  • The precautionary principle is applicable if the safety of the botanical ingredient used to fortify food cannot be assessed and if there is any uncertainty. 
  • Additionally, criteria for evaluating the safety hazards associated with novel foods should be explicitly stated and established. The European Food Safety Authority should conduct such assessments to ensure the scientific evaluation of novel foods is consistent. 

The EU Food Safety Authority takes stringent measures to protect consumer health and executes measures to ensure the food consumed is safe [1]. 

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