Before introducing such foods to the market, obtaining full marketing authorization is mandatory to demonstrate the safety of the food under the intended conditions of use. The applicant is responsible for providing evidence of the novel food’s safety through a comprehensive dossier. This dossier typically consists of the following main sections:
- Identity of the novel food: Detailed information about the food’s identity.
- Production process: Description of the methods used to produce the food.
- Compositional data: Information on the food’s composition.
- Specifications of the novel food: Specifications outlining quality and safety standards.
- History of use: Historical background of the novel food and its source.
- Proposed uses and use levels: Explanation of how the food will be used and recommended consumption levels.
- Absorption, distribution, metabolism, and excretion: Information on how the body processes the food.
- Nutritional information: Details regarding the food’s nutritional content.
- Toxicological information and allergenicity: Data related to potential toxicity and allergenic properties of the food.