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).