title: The EFSA health claims 'learning experience'.
abstract: The European Food Safety Authority (EFSA) has recently highlighted the need to provide scientific requirements for health claims and to find new regulatory issues for healthy food products. For this reason, EFSA asked its Dietetic Products, Nutrition and Allergies (NDA) panel to draft additional guidelines on scientific assessment of these claims. A new approach for a strict substantiation of health issues in selected fields: the Regulation (EC) No. 1924/2006 established in fact that health claims applications should only be authorized after a high level of scientific validation conducted by EFSA using appropriate measures in this evaluation. The legislation should not only protect consumers but also define specific research areas with appropriate outcome measures to assess the quality, relevance and adequacy of studies conducted for scientific validation of health claims. The new system was not only a necessary support for consumers to make the correct choice of products, but rather a way for EFSA to demonstrate transparency of this new approach. This was the field of the pharmaceutical industry, this new regulation is, therefore, also for EFSA, an expensive learning process.
authors.affiliation: Internal Medicine and Gastroenterology, Gemelli Hospital, Catholic University, Rome, Italy.
authors.forename: Vittoria
authors.initials: V
authors.lastname: Vero
authors.forename: Antonio
authors.initials: A
authors.lastname: Gasbarrini
mesh_terms: D019587:Dietary Supplements / Q000009:adverse effects / Q000032:analysis; D005062:European Union; D055317:Evidence-Based Practice; D005515:Food Labeling / Q000331:legislation & jurisprudence; D059022:Food Safety; D005527:Food, Fortified / Q000009:adverse effects / Q000032:analysis; D055951:Functional Food / Q000009:adverse effects / Q000032:analysis; D006078:Government Programs / Q000639:trends; D017408:Guidelines as Topic; D006293:Health Promotion; D006801:Humans; D007881:Legislation, Food