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The BfR’s recommended maximum levels

Studies such as the National Nutrition Survey II prove: On average, adults in Germany consume sufficient amounts of vitamins and minerals via their normal diet. For many of these substances, the intake reference values of the German Nutrition Society are even exceeded. And although scientific studies show that no positive health effects can be expected from an additional intake of micronutrients that exceeds the requirements, roughly one third of the population regularly takes food supplements. If high doses of micronutrients are taken or if foods enriched with vitamins and/or minerals are consumed, the risk of micronutrient oversupply may increase.

In the best case, excess nutrients are simply excreted. Sometimes, however, an oversupply of vitamins or minerals can have undesirable consequences. For example, a good supply of vitamin D ensures bone stability and, according to scientific studies, can reduce the risk of falls and bone fractures. However, those who regularly consume high amounts of vitamin D (more than 100 micrograms per day) without medical reasons, risk the formation of kidney stones or kidney calcification.

In order to limit the health risk of an oversupply of vitamins and minerals, it is intended in the EU regulations for food supplements and fortified foods to set uniform maximum amounts for these products at EU level. Such maximum amounts do not exist, yet.

The German Federal Institute for Risk Assessment (BfR) has been dealing with the issue for about two decades and, after assessing the health risks of vitamins and minerals, first developed maximum recommended amounts for vitamins and minerals in food supplements and fortified foods in 2004. These were updated in 2021 according to the current state of knowledge and are intended to contribute to the development of Europe-wide maximum levels.

How were the proposed maximum levels developed?

The tolerable upper intake level (UL) of the respective nutrient derived by the European Food Safety Authority (EFSA) was taken into account for the maximum level proposals. This is the amount which, according to current knowledge, is not associated with adverse health effects in the case of chronic daily intake of a nutrient from all sources.

In addition, the dietary reference values derived by the D-A-CH societies (German, Austrian and Swiss Societies for Nutrition; DGE, ÖGE and SSG/SSN) and the EFSA were used and finally the vitamin and mineral intakes from the usual diet determined in nutrition surveys (e.g. National Nutrition Survey (NVS II) and EsKiMo II study).

Taking these data into account, it was determined what amounts of vitamins and minerals can be added to food supplements and fortified foods to provide consumers with additional nutrient intakes while protecting the majority of the well-supplied population from excessive nutrient intakes.

The derivation of the maximum levels was based on an uncertainty factor in order to take into account substance-specific scientific uncertainties as well as the fact that some consumers take several food supplements, some of which contain the same vitamins or minerals.



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