On 27 December the Spanish Royal Decree regulating the notification of foods for specific population groups was published in the official national bulletin (Real Decreto 1412/2018, de 3 de diciembre, por el que se regula el procedimiento de comunicación de puesta en el mercado de los alimentos para grupos específicos de población). Successively, an information guide has been published by the Spanish authorities clarifying the situation of foods for specific groups as the new legislation on food for specific groups will gradually enter into full application in the following 2 years.
Foods for specific groups cover three main food groups that require to be notified in line with the European Union framework Regulation 609/2013. These comprise (i) infant and follow-on formula, (ii) processed-cereal based food and other baby food, (iii) food for special medical purposes and (iv) total diet replacement for weight control. In addition, the Spanish Decree differentiates between (a) infant formula, (b) follow-on formula prepared from protein hydrolysates and (c) follow-on formula containing other substances than those listed in Annex II of EU Regulation 2016/127.
At EU level, Regulation 609/2013 is supplemented by three delegated Commission Regulations regulating the compositional and specific labelling requirements of the individual food categories (Regulation 2016/127, Regulation 2016/128 and 2017/1798). The information guide provides a concise overview of the main changes with regard to composition and labelling as well as the specific dates these new requirements – different for the distinct food categories – will apply.
The obligation to notify the products with the member states they are placed on the market stems from the EU Regulations. The modalities, except for the provision of model of the label, are to be established by the member states. Royal Decree 1412/2018 being the result. The Spanish Decree requires that operators notify the competent authorities of the placing on the market as well as any changes to the labelling of the product or in case the product is taken from the market. At present, a notification fee of 927 euro applies for the first notification for one of the abovementioned products. A notification for the reason of modification amounts to 274,32 euro. In case the responsible operator has its registered office in Spain the notification needs to be presented with the competent body of the corresponding autonomous community. In other cases, the notification shall be directed to the Spanish food safety authority (AECOSAN) based in Madrid.
AECOSAN - Informe sobre la situación de los alimentos dietéticos /alimentos para grupos específicos con la aplicación del reglamento (ue) nº 609/2013 rev.2 - link