Maximum levels for vitamins and minerals in food supplements and fortified foods

The market of food supplements and fortified foods is diverse and continuously growing. Advertisements promise positive effects on health, well-being and performance. Approximately one third of adults in Germany regularly use food supplements, many of which contain vitamins and minerals. However, nutrient intake data indicate that in Germany, intake of only a few vitamins and minerals, including vitamin D, calcium, folic acid and iodine, does not meet the intake recommendations given by the German Nutrition Society (DGE e.V.) in some population groups. The rule of thumb is that a balanced and varied diet provides a healthy body with sufficient amounts of essential nutrients. If, in addition, one takes highly dosed food supplements and, possibly, also consumes fortified foods, the risk of an excessive intake of the micronutrients in question increases. For around two decades, the German Federal Institute for Risk Assessment (BfR) has been involved with assessing the health risks of vitamins and minerals, and had already developed proposals for maximum levels for food supplements and fortified foods for the first time in 2004. These have now been revised based on new scientific findings. "The more the better - this is also a misconception when it comes to vitamins and minerals," says BfR President Professor Dr. Dr. Andreas Hensel. "The dose determines whether they benefit or harm our health".

BfR opinion on the updated recommendations for maximum levels:

Vitamins and minerals topic page:

The BfR frequently shares opinions on health risks posed by food supplements and informs consumers about health problems that may be associated with using these kinds of products. There are currently no binding maximum levels for vitamins and minerals in food supplements and fortified foods at the German national or the European level. With this in mind, the BfR has re-evaluated its previous proposals for maximum levels and revised them based on new scientific findings. These are intended to serve the risk managers as a basis for discussion and, ultimately, as a basis for the establishment of maximum levels regulations at the EU level.

The BfR recommendations aim to limit nutrient intake via food supplements and fortified foods in such a way that significant additional nutrient intakes are achievable by use of these products, while at the same time, the majority of the well-supplied population are protected from excessive nutrient intakes. In deriving the maximum levels, consideration was given to three essential parameters: the European Food Safety Authority’s (EFSA) tolerable upper intake levels (ULs), the intake of vitamins and minerals via the usual diet, and the respective dietary reference values (DRVs). In the first step of deriving maximum levels recommended for food supplements and fortified foods, the BfR established the difference between the UL and the nutrient intake of high consumers from a usual diet.

To ensure that health impairments from consuming food supplements or fortified foods are very unlikely not only for adults, but also for adolescents, the age group of 15-to-17-year-olds was chosen as reference group for the derivation of maximum levels for food supplements. Moreover, an uncertainty factor of 2 was applied for almost every nutrient, to take account of scientific uncertainties and possible multiple exposure caused by the intake of different food supplements. When deriving maximum levels for fortified foods, the ULs and nutritional behaviour of younger children were taken into account.

For some of the maximum levels for food supplements, the BfR recommends additional mandatory information on the product labels. Furthermore, the BfR would also like to call attention to the fact that new scientific findings and future market developments might make it necessary to adjust the maximum levels.

About the BfR

The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. It advises the German federal government and German federal states ("Laender") on questions of food, chemical and product safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.

This text version is a translation of the original German text which is the only legally binding version.

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