Spain – New regulation for Food Supplements
After 9 years of the publication of the Spanish legislation that regulates the food supplements in Spain (Real Decreto 1487/2009, which only regulates the addition of vitamins and minerals) the Spanish Government has regulated the substances other than vitamins and minerals that may contain food supplements by publishing the Real Decreto 130/2018.
Similar legislation to that Real Decreto have already been developed in other European Union Member States, so these products were already marketed in Spain coming from other EU countries.
Real Decreto 130/2018 establishes a list of what these "other substances" different from vitamins and minerals food supplements may contain. For the confection of this list, the reports of the Scientific Committee on Human Nutrition and of the European Food Safety Authority, as well as the safety assessments carried out by other international organizations of recognized scientific standing, have been taken into account. Additionally, a safety assessment has been carried out by the Scientific Committee of the Agencia Española de Consumo, Seguridad Alimentaria y Nutrición (AECOSAN), which has established the recommendations of maximum daily doses and in some cases warning sentences aimed at the final consumer. Moreover, substances traditionally considered as "dietetics", and today “out” of regulation, have been included, like wheat germ, pollen, royal jelly, beer yeast, soy lecithin and propolis.
Therefore, the aim of that legislation is to allow the use of ingredients other than vitamins and minerals, in the elaboration of food supplements, provided there is sufficient scientific evidence to guarantee the safety of food supplements that contain these substances as ingredients, in order to facilitate the work of both the official control authorities and the food operators, while protecting the health of consumers.
Our Consulting Department can support every company who needs to review their labels in order to ensure the correct adaptation to the new regulation.
Source: Mérieux Nutrisciences Spain
