The situation regarding maximum intake levels of vitamins and minerals in the European Union (E.U.) is something of a never-ending story. It involves ongoing efforts by the European Commission and member states to establish harmonized limits to ensure consumer safety and the proper functioning of the internal market.

The European Commission, in collaboration with a task force of seven E.U. member states led by Germany and involving Belgium, Spain, France, Greece, Ireland, and the Netherlands, has been working on setting maximum levels for vitamin and mineral supplementation in fortified foods and food supplements. However, these maximum levels have not yet been finalized at the E.U. level, as the task is challenging due to the need to balance consumer safety with the nutritional needs of different population groups.

The maximum levels for food supplements (and for fortified foods) also need to be balanced against the background intake of nutrients from normal foods. Some nutrients, specifically those that accumulate in the body rather than being excreted, may reach critical amounts if supplemented in excess, or even at all.

The Chaos of Variation in National Regulations

In the absence of E.U. guidance, member states have long since taken matters into their own hands, devising their own maximum intake amounts, with significant differences between countries. Some of these maximum intake amounts are legally binding, and some are merely recommendations, all of which is leading to variations in national regulations across the E.U. that are chaotic and difficult to keep track of.

In France, for example, maximum levels have been devised to consider the age, physiological status, and health of different population groups, including children, adolescents, adults, pregnant women, and individuals with specific health conditions. French maximum intake amounts are legally binding. However, the French General Directorate for Food (DGAL) has announced a temporary halt to its planned update of the national nutrient decree for food supplements, stating that they will only resume work on updating national nutrient levels if E.U.-level harmonization efforts fail in the short term.

The German Federal Institute for Risk Assessment (BfR), on the other hand, has re-evaluated its previous proposals for maximum levels and revised them based on new scientific findings, aiming to serve as a basis for future E.U.-level regulations. However, at present, these levels are recommendations that FBOs are not legally required to observe. Still, some authorities do view them as binding, which in turn may lead to legal action without a legal basis.

The E.U.-wide harmonization efforts are additionally hampered by concerns regarding the necessity of supplementation that are occasionally raised by member states. At the forefront of these critical voices is Germany, whose authority BfR has repeatedly stated that current supplementation levels of some nutrients are too high. An example is concern about the widespread availability of high-dose vitamin D products. Another concern addresses the potential of vitamin K to interfere with anticoagulant medications. Some nutrients should not be supplemented at all according to BfR (e.g., CoQ10, phosphate, and chloride).

Finding a Common Denominator

As long as the E.U. Commission does not complete its evaluation of upper levels and incorporate these levels into E.U.-wide law, the situation is expected to continue. It goes without saying that this makes marketing food supplements for more than one E.U. country a bit challenging. The lowest common denominator (i.e., the lowest permitted upper intake level for the respective member state) limits the amount of each active ingredient, unless the FBO is willing to take some risks.

This, however, is also tricky to anticipate. As stated above, some maximum amounts that are only advisory are taken as legally binding by some, but not all, authorities in member states such as Germany, which increases the regulatory risk in unforeseeable ways. Thus, FBOs wishing to market food supplements containing vitamins and minerals in more than one E.U. member state, are well-advised to commission consultancies such as analyze & realize GmbH in order to minimize the risk.

About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: jgruenwald@a-r.com, www.analyze-realize.com