Assessment and Management of Health Claims in Europe 9 Years after the Adoption of the Regulation.

The European regulation 1924/2006 foresees that any nutrition or health claim should be assessed by EFSA and authorised by the European Commission and the Member States (with scrutiny by the European Parliament and the Council), the outcomes of which are published in the EU Register of Nutrition and Health Claims. Since 2007, EFSA has evaluated 230 dossiers submitted under Article 13.5 or Article 14. In addition, out of the 44,000 'general function claims', defined under Article 13.1, proposed by Member States, a list of 4,637 claims was compiled, EFSA completed evaluation of 2,849 of them, and published the results in 365 opinions, providing the basis for a list of 229 permitted health claims. For maintaining consistency over time and scientific areas, EFSA developed a systematic approach (for food characterisation, effect characterisation and scientific substantiation). Pertinent human studies of sufficient quality are central for the substantiation; any other study type can be used as supportive. This approach is summarized in 6 guidance documents. These guidance documents are revised progressively, which includes systematic submission to public consultation.