Regulation No. 624/2004 on food supplements.

This regulation governs food supplements, defined as foods intended to supplement the normal diet and supplied in measured doses, such as capsules, tablets, powders, ampoules or drops, containing vitamins, minerals or other substances with nutritional or physiological effects. It sets rules on which vitamins and minerals may be used, their permitted chemical forms and purity requirements, and requires food supplements to be labelled clearly as “dietary supplements,” with the relevant substance category, recommended daily intake, warnings not to exceed that intake, a statement that supplements are not a substitute for a varied diet, and a warning to keep them out of children’s reach. It prohibits claims suggesting that a balanced diet cannot provide sufficient nutrients or that supplements prevent, treat or cure disease. The regulation also requires nutritional labelling, operating licences for manufacturers, importers and distributors, notification to the Environment Agency when products are first placed on the market, and allows restrictions or prohibitions where supplements may endanger human health. It implements Directive 2002/46/EC and includes annexes listing permitted vitamins, minerals and their forms.