Food supplements: approximation of the laws of the Member States

PURPOSE : to present a Directive on the approximation of the laws of the Member States relating to food supplements. CONTENT : a wide range of products, known under the term food supplements, diet integrators or others, have been marketed in Community Member States for a number of years. The national rules applicable to them may differ substantially. This has led to obstacles to intracommunity trade that the application of the principle of mutual recognition did not succeed in overcoming. For a number of years now, there have been many comments received from Member States and other interested parties which emphasised the need to adopt Community rules on these products marketed as foodstuffs. The products in question are usually concentrated sources of nutrients and other ingredients, alone or in combination and marketed in dose form. These ingredients include, among others, vitamins, minerals, amino acids, essential fatty acids, fibre, various plant and herbal extracts. The task of covering products containing all these ingredients would be enormous and very complicated. It has therefore been decided for practical reasons to deal at this stage in detail with products containing vitamins and minerals. The measures may be amended in the future to cover in detail products containing other nutrients and/or ingredients. Furthermore, there is an important range of vitamins and mineral supplements on the market. They vary from single nutrient products of variable nutrient levels to multi-nutrient products also of variable nutrient levels for individual nutrients. Prevalence of one or the other product is determined by consumer preferences and differs from one Member State to another. Thus, the choice must be made exempt of any risks health by ensuring that products appropriate and correct information about these products through labelling. Ensuring that food is safe and providing adequate and clear information on the label have been two fundamental principles of Community food law. Another very important element regarding the safety of these products is the maximum levels of minerals they contain. These levels should therefore be stipulated in order to ensure their safety. Upper safe intake levels for some nutrients (e.g. vitamins A, D, B6 and folic acid, iron, selenium, zinc) may be close to amounts that are recommended as population reference intakes (PRI). Therefore, for these few nutrients the PRIs should be taken into account when setting maximum levels in food supplements. On the other hand, the setting of a minimum level of vitamins and minerals in these products is desirable in order to guarantee that food supplements contain a significant amount that would justify the intended purpose of the product. Once the principles for setting maximum and minimum limits have been agreed the adoption of specific limits or each nutrient, based on the opinion of the Scientific Committee for Food (SCF), is a technical matter and should be delegated to the Commission. It should be noted that excess intake of some vitamins and minerals may cause undesirable or adverse effects. Hence, the need to ensure the safety of these products which includes labelling the products with clear instructions about the use of the product, in particular the quantity to be consumed. Asit is, food supplements are excluded from the scope of Directive 90/496/EEC on nutrition labelling. Therefore, the specific relevant rules must be stipulated. These products contain hardly any significant amounts of energy, protein, carbohydrate or fat and, therefore their declaration in the nutritional labelling would be irrelevant. Their nature and intended use, however, as sources of vitamins and minerals would justify that labelling for these nutrients should be compulsory.�