Scientific Opinion on the substantiation of health claims related to fluoride and maintenance of tooth mineralisation (ID 338, 4238) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to fluoride and maintenance of tooth mineralisation. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is fluoride. The Panel considers that fluoride is sufficiently characterised. The claimed effects are “minerals are essential micronutrients for humans and must be regularly supplied with the food or by supplementation; the indispensability of regular intake is expressed in the need for official Recommended Dietary Allowances (RDAs) elaborated by scientific expert committees and published by health authorities” and “oral health”. The target population is assumed to be the general population. In the context of the proposed wording and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the role of fluoride in the promotion of a beneficial balance between de- and remineralisation of tooth enamel, and therefore relates to the maintenance of tooth mineralisation. A claim on fluoride and maintenance of tooth mineralisation has already been assessed with a favourable outcome.