Fortification of foods (Spain)

Fortified foods are ordinary foods to whom some other substances have been added. Their legal framework in Spain sticks EU Regulations. Therefore, Regulation EC 1925/2006 of the European Union on the addition of vitamins and minerals and of certain other substances to foods and its implementing Regulations (Commission implementing Regulations nº 307/2012, 489/2012, 2015/403, 2019/649, 2019/650, 2021/468, 2022/860 and 2022/2340) are directly applicable in Spain. Spain has not specific regulations or guidance besides these EU Regulations; therefore an authorization process is not required. However, Spanish Food Safety Agency (AESAN) has pointed out on several occasions that any source of any mineral or vitamin not already included in EU Regulations might be considered as a novel food (i.e. see the link https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_alimentaria/interpretaciones/nutricionales/Fuentes_Vit_Min_NF.pdf) Regarding significant amounts established in article 6.6 of Regulation EC 1925/2005, Spanish Food Safety Agency (AESAN) has made and exception for young children (1-3 years) formulae; these foodstuffs may apply the reference values of Annex VII of Regulation (UE) 2016/127 on infant formula and follow-up formula, instead of VRN of Annex XIII of Regulation 1169/2011 (link: https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_alimentaria/interpretaciones/nutricionales/VRN_Preparados_ninos_de_corta_edad.pdf)

This is general information rather than legal advice and is current as of 30 May 2024. We recommend you contact a specialised food lawyer for legal advice for your particular circumstances to support commercial decisions which could impact your product or business.

Silvia Bañares Vilella