The relationship between nutrition and health is gaining public acceptance and consumers are increasingly health-conscious and want to obtain more information about the food they buy. There is a legal void with regard to health claims in the European Union. The framework labelling legislation prohibits 'attributing to any foodstuff the property of preventing, treating or curing a human disease or referring to such properties'. In the absence of a specific Directive on claims for foodstuffs, EU member states apply different interpretations of the existing labelling legislation. Therefore, it may occur that a claim which is permitted in one country may be prohibited in another one, and vice versa. Because of this, manufacturers have to deal with a variety of regulations, guidelines and codes of conduct. As regards national self-regulation systems (guidelines, consensus documents, voluntary codes of practice, joint interpretation of law), increasingly their development in EU countries (UK, France, Belgium, Netherlands, Spain, Sweden, Finland), is an attempt to remedy the situation of legal uncertainty. In most countries, a coalition of industry experts, enforcement authorities, consumer representatives, and scientists was involved in the elaboration of rules for the scientific justification and formulation, communication and presentation of health claims. At the international level, Codex Alimentarius is currently debating a draft on Enhanced Function Claims and Reduction of Disease Risk Claims. The draft recommendation is currently at step 3 of the Codex procedure. A lot of work has been undertaken internationally (Codex), in the EU (FUFOSE) and beyond (Council of Europe) in order to demonstrate that scientific substantiation of claims is possible and to establish valid criteria for this process.