Food Regulatory Procedures in the EU and the US

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

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• 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.

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• 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.

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• 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.

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• 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.

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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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