Maximum-levels report sparks concern in EU

A 340-page German government agency report on maximum levels for vitamins and minerals has drawn a guarded reaction from industry groups alarmed by its potentially restrictive influence on pan-European levels to be set later in the year.

?In general the BfR proposal for maximum levels in food supplements and fortified foods are very low,? said Dr Rose Schraitle, head of regulatory affairs at the German Medicines Manufacturers Association. ?If the BfR proposal came into force, some trace elements such as iron, copper and manganese would not be permitted in food supplements as they are now.?

Compiled by the German Federal Institute for Risk Assessment (BfR), the report is at odds with the UK?s Expert Group on Vitamins and Minerals report (EVM), and includes a 225mg maximum for vitamin C (EVM ? 1000mg), 5.4mg for B6 (EVM ? 10mg), and 9mcg for B12 (EVM ? no maximum).

?We have concerns with the fact the BfR has used an arbitrary factor to reduce the upper levels, consequently resulting in levels that are fairly consistent with existing German practice or even lower,? said Lor?ne Courr?ge, director of regulatory affairs at the European Health Product Manufacturers Association (EHPM). ?While the European Commission is obliged to use the European Food Safety Authority levels as its starting point, the German approach, along with the UK?s EVM report, will be discussed.?

Maurice Hanssen, president of the UK-based Heath Food Manufacturers Association, questioned the BfR claim that it is the first to employ an ?all nutrient sources including food? scientific risk analysis. ?The EVM did that in their 2003 report,? he said. ?It?s not BfR?s methodology but their interpretation of it that accounts for the low levels.?

Report author Dr Rolf Gro?klaus defended the findings. ?Our methodology is very different from the UK method because we give more weight to other nutrient sources such as functional foods and regular foods,? he said. ?Supplements manufacturers in the UK or the Netherlands might look at our levels and think they are too low, but they need to look carefully at our risk assessment method because practise in some European markets is dictated by marketing rather than scientific principles. Food supplements are not meant to cure diseases or be fed to babies. All sectors of the population need to be protected.?

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