"New function” health claims under Article 13.5
Claims under article 13/5 EC Regulation on nutrition and health claims are those based on newly developed scientific evidence and/or for which protection of proprietary data is requested. For these health claims authorisation is required on a case-by-case basis, following the submission of a scientific dossier to EFSA for assessment.
Valid applications are transmitted to EFSA by competent authorities in Member States. EFSA is then required to deliver its opinions within five months. If supplementary information is needed, EFSA has an additional month for the evaluation.
Article 13.5 applications submitted to EFSA are included in the Register of Questions, with indication of the food substance and claimed effect. The panel has received to date 48 applications, 13 have been withdrawn and so far 27 scientific opinions have been adopted.
For confidentiality reasons, and in accordance with the claim regulation, summaries of these Article 13.5 claims applications are not published.