EFSA Info session on the preparation and safety assessment of applications for market authorisation of novel foods - NDA - Technical meeting with Stakeholders
On 6 March 2017, EFSA met with stakeholders to present and collect feedback on the preparation and safety assessment of applications for market authorisation of novel foods. About 130 participants, including applicants, representatives of industry associations, consultants, representatives of national competent authorities from Europe and outside of Europe and academics met with EFSA experts of the Working Group on Novel Foods of the NDA Panel, EFSA Scientific Officers and a representative of the European Commission.
The objective of the meeting was to engage in open dialogue with stakeholders on the scientific requirements set by the EFSA guidance documents for the preparation of applications for market authorisation of novel foods and of notifications of traditional foods from third countries, and on how EFSA assesses such dossiers.
Participants discussed compositional data and the production process of novel foods, the history of consumption, toxicological data, nutritional information, human studies and allergenicity.
Attendants participated actively in the discussions and considered the meeting as an important opportunity to enhance constructive dialogue and increase engagement with EFSA.
The agenda, list of participants, and presentations given at the technical meeting are available below.
- 1. Van Loveren - General principles and their relevance for the safety assessment
- 2. Heinonen - Composition, production process and specification
- 3. Arcella - Intake assessment
- 4. Gelbmann - History of consumption and dietary intake from other sources
- 5. Schlatter - Key issues regarding kinetic data
- 6. Neuhauser-Berthold - The relevance of nutritional information
- 7. Neuhauser-Berthold - Human studies pertinent to the safety assessment
- 8. Schlatter - From animal toxicity studies to safe levels of intake in humans
- 9. Marchelli - Allergenicity assessment
- 10. Gelbmann - Experience of use of a traditional food in a third country & safe conditions of use in the EU