Health-Related Claims of Food Supplements: Regulatory Framework in Europe and Its Implications for Consumers HealthД¬onsumers should be properly informed about the health benefits provided by the consumption of food supplements in order to ensure their safe use. Apparently there were no alerts regarding folic acid in the studied period. The second cause of these notifications was the overdose of vitamins and minerals (87/463 notifications, that is, 18.8 %). In the last five years (1 January 2015вЂ“31 December 2019), the RASFF received 848 notifications related to food supplements in Europe. ДЇood supplements are included in the Rapid Alert System for Food and Feed (RASFF). The results concluded that high dosages (>1000 Вµg/day) of folic acid could provoke undesirable modifications in fetus neurodevelopment or even the appearance of side effects (diabetes, thyroid disorders, allergies, etc.). As an example, Brown and Wright (2019) carried out an extensive literature review focused on the key functions of folic acid during pregnancy as well as on the efficacy and safety of food supplements for pregnant women. The European Directive 2002/46/EC (last amendment in 2017) establishes a list of vitamins, minerals, and their sources allowed for use in food supplements, although safety dosage limits have yet to be established.ДЇood supplements could involve risks for consumerвЂ™s health.

Food SupplementsвЂ™ Safety: An Overview of the State of the Art According to the EuroPrevall Birth Cohort, a multi-center study carried out in nine European countries, the most commonly used food supplements by European pregnant women are those with folic acid, and Spain is the country with the highest consumption of food supplements (97.8% of Spanish pregnant women). This percentage greatly increases up to 59.4% for pregnant women, a specific group of the population whose nutritional requirements (especially micronutrients such as folic acid) are increased. In 2016, more than the 25% of the European population consumed food supplements to complement the habitual diet or maintain an adequate health status. The consumption of food supplements is increasing in Europe. All samples included accurate dosages and met the legal requirements (European Regulations 1924/2006, 432/2012, 1169/2011) for all approved claims for folic acid.ДЇood supplements are concentrated sources of nutrients (vitamins and minerals) or other substances (e.g., amino acids) with a nutritional or physiological effect, which are aimed at supplementing the normal diet for a specific period of time to reduce the risk of a specific disease. The analytical results for folic acid content in the selected samples were consistent with the declared values and within the tolerance ranges established in the European Guidance document. The results showed that nine health-related claims are currently approved for folic acid in Europe. Authors performed (1) a review of health-related claims approved for folic acid in Europe, (2) a market research of food supplements commercialized in Spain with those claims, and (3) a selection of food supplements for chemical analysis in the lab to assess these claims. The objective of this work was to assess the compliance level of health claims related to folic acid in food supplements commercialized in Spain according to the European regulation. As consumers increasingly rely on food supplements, it is vital to properly inform them about the health benefits provided by supplementsвЂ™ consumption to ensure their safe use. The daily intake of folic acid, a crucial vitamin for embryonic development, must be reinforced through supplementation, as sometimes diets are not well equilibrated. Pregnant women are a vulnerable group with increased nutritional requirements.

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