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Food Regulatory Procedures in the EU and the US

Innovative foods or ingredients may need to undergo certain regulatory procedures prior to being marketed in Europe and in the US:

  • Product notification: EU regulations establish that food supplements must be notified to the competent authorities before or simultaneously to their placing on the market, by a registered Food Business Operator.

  • Novel Food procedure: foods and food ingredients not consumed to a significant degree by humans in the EU before 15 May 1997 need to undergo an authorization process with EU authorities before they are commercialized for the first time.

  • Health Claim procedure: Under European law, all health claims made on foods must be authorized by the European Commission. Health Claim applications must be scientifically substantiated to gain authorization.

  • GRAS procedure: Innovative food ingredients to be added to foods in the US may require GRAS (Generally Recognized As Safe) status for specific intended uses.

All these procedures involve both technical and regulatory requirements of potentially high complexity, in which Sandwalk experience can dramatically increase your likelihood of success.

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