Regulations for Food Supplements and Nutraceuticals in Europe

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Regulations for Food Supplements and Nutraceuticals in Europe (1)

Regulations for Food Supplements and Nutraceuticals in Europe

Food supplements and nutraceuticals in Europe are regulated by the European Union’s (EU) Food Supplements Directive (FSD) and the Novel Foods Regulation (NFR).

  • In the EU, food supplements are considered food and, therefore, regulated the same way food is regulated.
  • The FSD sets out rules for the composition, labelling, and marketing of food supplements. At the same time, the NFR outlines the requirements for authorizing novel ingredients in food products, including food supplements and nutraceuticals.
  • Under the FSD, food supplements must be safe for human consumption and contain specified vitamins, minerals, and other substances in specific amounts.
  • The FSD also establishes the maximum amounts of vitamins and minerals that can be added to food supplements. In addition, food supplements must be labelled with specific information about their contents and recommended daily dose.
  • The definition of a food supplement excludes adding nutrients or other ingredients to fortify food, which is covered by Regulation (EC) 1925/2006.
  • The NFR requires companies to submit an application for authorization of any novel food ingredient not consumed in the EU before May 15, 1997. The application must include detailed information about the ingredient’s composition, intended use, and safety data. Once authorized, the ingredient can be used in food products, including supplements and nutraceuticals.
  • According to Regulation (EC) No 2015/2283 on novel foods, EFSA is asked to provide a scientific opinion on a substance’s safety if it hasn’t previously been used in the EU without incident before 1997 [1].

 

The regulatory framework for food supplements and nutraceuticals in Europe aims to ensure the safety and efficacy of these products while promoting consumer access to the products.

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