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Evaluation of the regulatory status of the food additive, within the European Union (regulations 1333/2008).

Scientific pre-diagnosis of the data, in accordance with regulatory requirements of admissibility

  • Analysis of additive characterization data and analytical methods
  • Exposure Calculation
  • Analysis of the pharmacokinetic and stability data of the additive
  • Analysis of safety/toxicity and allergenicity studies on the additive

Recommendations from our experts

  • Strengths and weaknesses of the rationale
  • Additional information to be provided, including any toxicological and/or quality studies to be carried out.

Constitution & submission of the dossier

  • Constitution of the request for authorization
  • Submission to the European Commission

Follow-up & exchanges with the authorities (EFSA, European Commission).

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