Report of the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) on the conditions of use of certain substances to be used in food supplements-4

Food supplements are foods, the purpose of which is to supplement the normal diet and which consist of concentrated nutrient sources (vitamins and minerals) or other substances with a nutritional or physiological effect, alone or in combination. The supplements are marketed in dosage form and are only supplied to the end consumer prepacked. In no event should they replace the use of medicines without suitable medical supervision. They should only be used to supplement the diet and, on the whole, their usage is not required if the individual has a varied and balanced diet, which cannot be replaced. In Spain, food supplements are regulated by Royal Decree 1487/2009, which transposed Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements into Spanish law. However, only the use of vitamins and minerals is currently regulated. Therefore the Scientific Committee has been asked to make an assessment of the proposal to authorise certain substances other than vitamins and minerals in the manufacture of food supplements. The substances proposed by the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) are L-aspartic acid, L-citrulline, glycine, L-proline, L-serine, L-arginine-L-aspartate, L-lysine-L-aspartate, L-lysine-L-glutamate, N-acetyl-L-cysteine, N-acetyl-L-methionine, hidroxymethylbutyrate, lipoic acid, Monascus purpureus, activated carbon and lactulose. The Scientific Committee has assessed each proposal, analysing the characteristics and sources of each substance, and the nutrition, metabolism and safety and has concluded, in each case, whether that submitted by the AECOSAN is acceptable from a safety viewpoint for use as a food supplement. In no event is the assessment intended as a guarantee of the biological efficiency of the substances and the estimated doses. The Scientific Committee states that, in any case individuals undergoing medical treatment must seek medical advice as to the suitability of taking food supplements, given the possibility of interactions in certain cases. In addition, in the case of food supplements with an antioxidant effect, it should be noted that in certain conditions and at high doses, these compounds may behave as pro-oxidants.