05.01.07
European Federation of Associations of Health Product Manufacturers (EHPM), Brussels, Belgium, has welcomed the European Food Safety Authority’s (EFSA) “pre-submission guidance” on applications for the authorization of certain health claims. The document, which is available on EFSA’s website, covers applications for disease risk reduction and children health and development claims (Article 14), and health claims based on newly developed scientific evidence or proprietary data (Article 18) of the Nutrition and Health Claims Regulation. It includes several key points, notably that separate applications are necessary for every health claim; that the summary of the dossier should not contain confidential information as it will be published on EFSA’s website, and that an English summary of the application is required. EFSA’s Scientific Panel on Dietetic products, Nutrition and Allergies (NDA Panel) is currently developing further guidance to assist all companies in preparing and presenting their applications under Articles 14 and 18 of the Nutrition and Health Claims Regulation.