Are new German recommendations for maximum vitamin and mineral levels 'unreasonable'?

The German Federal Institute for Risk Assessment (BfR) report proposes levels that can be used by the German government to set future national maximum levels.

While not legally binding, the report suggests no maximum tolerable upper intake levels (UL) for Vitamin B1, vitamin B2, pantothenic acid and biotin, and proposes an increase of UL levels for vitamin D, niacin, vitamin B12, vitamin C, vitamin E, zinc, manganese over recommended values set by the BfR in 2004.

However, legal expert Luca Bucchini, managing director of Hylobates Consulting, is critical of the approach stating used by the BfR - warning that the proposed limits lack credibility on both a scientific and regulatory basis.

He warned that the German authority has been 'extremely precautionary' with the revisions of its maxiumum levels - citing examples for vitamin D, which stated at 25 ug while when several other European Member States look to set limits of 75 ug, and vitamin B12 which is also proposed to be set at 25 ug while other Member States have existing limits of 1000 ug

The report also suggests keeping the UL outlined in its earlier guidelines for iron, copper, potassium, chromium, molybdenum, sodium (= 0), chloride (= 0), calcium, magnesium, iodine, fluoride (= 0) and vitamin K.

“The maximum levels proposed here provide protection against excessive nutrient intakes for the greater part of the well-served population, which can be associated with an increased health risk in the long term,”​ the report said.

“They are based on exposure estimates and risk assessments of high nutrient inputs, taking into account the usual diet and the (potential) use of micronutrients for food fortification."​

The BfR model​

The UL defines the daily intake of a nutrient from all sources, which include supplements (NEM) and fortified foods.

Although exceeding the UL does not necessarily lead to undesirable effects on health; it can increase the risk for it.

The BfR explained that since NEM should be safe for the whole population, the needs of the most sensitive group—persons over 15 years of age—were taken into consideration.

Therefore, the lower ULs of 15- to 17-year-olds were taken, so that products deemed safe for this age group would also prove so for the wider population.

The BfR model remains the only one in Europe that links NEM and fortified foods. This is important, as maximum levels for one of the two product groups always have an impact on the other.

A cautious approach ​

However, Bucchini, says the model used is “expressed in a concept with no precedents in EFSA's or any other major international scientific body.”​

“They halve maximum levels because people may take two vitamin D supplements with maximum levels of vitamin D, and assume that label warnings cannot solve the issue. ​

“Such a position is unlikely to withstand the test of EU case-law: on the first count, the risk assessment is at odds with internationally recognised procedures; on the second count, reducing maximum levels without considering labelling changes is not proportionate.”​

Bucchini added that BfR’s method of equally dividing the maximum amount between food supplement and fortified foods, in the case of vitamin D is ‘not reasonable’.​

“Intake of vitamin D in food supplements is easy to control (number of tablets per day, for example), whereas that of fortified food is not (for example, consumers may eat more than one serving of cereals). ​

“Again, this is not proportionate, and courts would likely find that maximum levels based on this type of peculiar scientific assessment does not suffice to limit the free movement of food supplements in the EU.​

“The grounds for setting the maximum levels of vitamin B12 are even less in compliance with EU law, as it ignores EFSA's upper intake tolerable level.”​

Further details on the calculation method and the proposed maximum levels can be taken from the publication below (in German).

Source: Journal of Consumer Protection and Food Safety​
Published online ahead of print, doi: 10.1007/s00003-017-1140-y​​
“Maximum levels of vitamins and minerals in dietary supplements.”​
Authors: Anke Weißenborn et al​.