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.
Our services for novel foods encompass the following
Determination of Novel Food Status

This involves assessing the novel food status of your ingredient, including consultations with relevant authorities to ascertain its regulatory classification.

Gap Analysis

We conduct a comprehensive gap analysis to identify the required data necessary for developing the novel food dossier.

Nutritional Value Evaluation

Our team evaluates the nutritional value of your ingredient to ensure it aligns with regulatory standards.

Dossier Compilation

We undertake the task of writing all sections of the novel food dossier, ensuring it is complete and compliant with regulatory requirements.

Toxicological and Safety Review

Our experts perform a thorough review of the toxicological and safety aspects of your ingredient to assess its suitability for consumption.

Dossier Submission

We handle the submission of your novel food dossier to the relevant authorities and actively manage the follow-up process, addressing any questions or requests for additional information.