The Spanish Agency for Food Safety and Nutrition (AESAN) recently published updated guidelines for probiotics (1) and prebiotics (2) in foods.
Despite the existence of a European regulatory framework for foods, food ingredients and health claims, many Member States have additional regulations affecting their formulations, labelling and health claims. In Spain, this regulation may be even more confusing than in other European countries.
First, in Spain, and unlike in some other Member States, pre-market notification is compulsory for food supplements. The system, the competent authority and the notification fees vary if the notifying company is established in Spain or in a different country. Even for companies based in Spain, the competent authority and the official notification fee are dependent on the precise location of the company within the territory. For example, fees per notified product range from €60 for companies based in Madrid up to over €900 for companies based in a foreign country.
Despite the relatively recent update in Spanish regulations (3) in which, for the first time, ingredients other than vitamins and minerals were allowed in food supplements, technically all probiotics and any prebiotics outside beta-glucans, chitosan and FOS are NOT allowed in food supplements.
In order to get their products cleared in Spain, companies (both national and international) are using the Mutual Recognition, which derives from the case-law of the Court of Justice of the European Union, and by which Member States may not prohibit the sale on their territory of goods which are lawfully marketed in another Member State, even where those goods have been produced in accordance with different technical rules. Using this procedure, only adjustments in labelling to language and other requirements, including health claims, is necessary for commercialization in Spain. Although this system is already working, it may further benefit from the new Mutual Recognition Regulation, which will apply from April 19th, 2020 (4).
Guidelines published recently by AESAN do not really add more clarity about this situation and its challenges. However, the increasing interest from the authorities and the very use of the terms probiotic and prebiotic are always regarded by the industry as a small step forward towards a greater regulatory certainty around these food ingredients.