For the first time, Spanish manufacturers will be able to include very well known ingredients such as Omega-3 fatty acids, L-Carnitine, lycopene or fructooligosaccharides in the composition of food supplements without having to notify their products in another EU country and then use mutual recognition. This situation, the new law admits, was diminishing the competitiveness of Spanish companies within the framework of the EU market.
This is the result of a long-awaited list of other substances with a nutritional or physiological effect that may be used in the production of food supplements has finally been published in the Spanish Official Gazzette, nine years after the implementation of Directive 2002/46/EC.
However, the list of around 60 substances of Royal Decree 130/2018 falls short of the around 400 substances that, according to the same law, are currently being added to food supplements in the EU. Also, the list does not include any plants or botanical extracts, which means that the situation will not change much for the Spanish producers in practice.
A mutual recognition clause has been added, enshrining the now well accepted practice of allowing food supplements legally marketed in other EU countries, even if they contain botanical extracts or other substances not included in the Spanish positive list.
However, it remains to be seen whether the new maximum limits laid down in the Real Decreto 130/2018 [e.g. a maximum daily dose of 3 grams for omega-3 fatty acids (DHA + EPA)] and the mandatory warnings for some substances (e.g. "Must not be consumed by pregnant women and nursing mothers or by children" in products containing glucosamine) will also apply in spite of the mutual recognition clause, since the safety of these substances has been evaluated by the Scientific Committee of the Spanish Agency of Food Safety and Nutrition.
Real Decreto 130/2018, de 16 de marzo, por el que se modifica el Real Decreto 1487/2009, de 26 de septiembre, relativo a los complementos alimenticios.