ABSTRACT
In the European Union, amino acids, enzymes, pre- and probiotics, essential fatty acids, botanicals and botanical extracts and miscellaneous bioactive substances can be marketed as food supplements (FS). Food supplements that are meant to benefit human health contain claims on their label stating their benefits. Since 2007, health claims made on FS, are prohibited unless they are authorized and included in the EU Register of Nutrition and Health Claims on Food (the EU Register), in accordance with the requirements of Regulation (EC) nº 1924/2006. Aims: This manuscript reviews the evidence required to support health claims made on FS considering the legal framework of these foodstuffs and, as a case study, analyses the health claims on articular joint health included in the EU Register. The EFSA scientific opinions related to those health claims have also been considered. In EU, some botanicals and miscellaneous bioactive substances can be marketed as medicinal or as food supplements. The regulatory issues on botanicals and the debate on how to create a regulatory framework for botanicals is mentioned. Results: By April 2015, 77 functional health claims on joints health were included in the EU Register. The status of all these claims was non-authorised. The great majority were Article 13.1 claims (91%). All functional claims related to articular joints function were made on target functional ingredients, mainly other substances that could be used in the manufacturing of FS. Human trials conducted in diseased population were the main statement from EFSA for the non-approval of the health claims on articular joints. Criteria and more guidance addressing methodological issues on human trials would benefit future applications and scientific research. Conclusion: Legal issues regarding other substances than vitamins and minerals, namely botanical ingredients should also be taken in account in future FS health claims on articular joints. On this subject, efforts to improve the existing regulatory framework, namely with regard to botanicals products could also benefit future FS health claims.