Scientific data to be provided in a notification or an application
Article 6
1. The dossier submitted in support of a notification or an application for the authorisation of a traditional food from a third country shall enable a history of safe use of the traditional food from a third country to be assessed. 2. The applicant shall provide a copy of the documentation on the procedure followed when gathering the data. 3. The applicant shall provide a description of the safety evaluation strategy and shall justify the inclusion and exclusion of specific studies or information. 4. The applicant shall propose an overall conclusion on the safety of the proposed uses of the traditional food from a third country. The overall evaluation of potential risk to human health shall be made in the context of known or likely human exposure.