The Expert Group on Vitamins and Minerals first met in 1999 to consider the safety in long-term use of vitamin and mineral supplements sold under food law with a view to recommending maximum advisable levels of intake. Since then it has endeavoured to work as openly as possible. Thus, its agendas and working papers have been freely available, and observers, nominated by Interest groups, took a full part in reviewing pertinent evidence, all with the objective of ensuring as full and balanced a review of evidence as was practicable. In keeping, the draft report was then made freely available for comment, so giving a second opportunity to ensure all relevant evidence was addressed, and addressed properly.As a result of that consultation in the autumn of last year significant modifications were made to the draft. The determination of Safe Upper Levels or if that was not possible, Guidance Levels of intake had, of necessity, to take account of the possible effects on potentially susceptible individuals who could freely obtain vitamins and minerals and take them on a long-term basis. This implied that good quality large studies of appropriate duration were needed. The group could only work within the confines of existing evidence, and robust conclusions depended on the availability of adequate and relevant data, but in many cases the necessary information was incomplete.The final version of the report was agreed unanimously by members, it will be for others to decide if our recommendations, which are, in essence, risk assessments, should be followed by the adoption of altered risk management strategies. In this context it should be emphasised that our recommendations do not address the medicinal uses of vitamins and minerals, which lie within the remit of the Medicines and Healthcare products Regulatory Agency. Expert Group on Vitamins and Minerals 2003 Introductory Chapters Introductory Chapters Chapter 1 -Background to the establishment of EVM Chapter 1 -Background to the establishment of EVM UK regulation of products containing added vitamins and minerals In the UK, products containing added vitamins and minerals can be regarded in law as either foods or medicines 2 . Those products for which claims are made for the treatment or prevention of disease, or which are administered to restore, correct or modify physiological functions, fall within the definition of a 'relevant medicinal product' and are subject to the requirements of the Medicines Act 1968, Directive 65/65/EEC. Such products require a marketing authorisation (licence) before they can be sold or supplied and are regulated in accordance with the Medicines for Human Use (Marketing Authorisations, etc.) Regulations 1994 [SI 1884/3144]. Products that are licensed as medicines are excluded from the definition of food in the Food Safety Act 1990. The control of medicines is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA), which is an executive agency of the Department of Health.In Great Britain, products that are not regulat...