Typically, the applicant will need to use one counterpart food product as the means of demonstrating substantial equivalence of the novel food product. At a more detailed level, the applicant needs to provide data that show that the novel food product is substantially equivalent to the food counterpart in five key areas: composition; nutritional value; metabolism; intended use; and level of undesirable substances.
12 regulatory affairs Food Novel in Europe Approvals Routes to Obtaining Regulatory Approval for Nutraceuticals in the EU Regulation (EC) No. 258/97 con
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