A report from the German Federal Institute for Drugs and Medical Devices (BfArM) warned against the consumption of cholesterol-lowering monacolin K (MK) from red yeast rice, which it classes as medicinal at doses higher than 5 mg per day.
Last month the Belgian Superior Health Council also called for an immediate ban on the use of the ingredient in food supplements.
For some member states the ingredient is a drug while others classify it as a food supplement, and dosages used to draw this distinction differ across the bloc.
In Italy the maximum legal limit for MK in food stuffs and food supplements is 10 mg and in France supplements containing 10 mg or more are considered prescription-only drugs.
MK is not permitted in food supplements point blank in Switzerland and Iceland on the grounds it is a pharmacologically active substance.
Other countries like the Netherlands and Latvia do not have an upper limit, but require companies to prove levels do not correspond to a medicinal dose such as the 10 mg used for cholesterol drug lovastatin.
The German consumer group VZBV (Verbraucherzentrale Bundesverband) said this was not an issue of EU harmonisation however, since the distinction between pharmacological effects of drugs and physiological or nutritional effects of food was clear under EU law. Instead she said it was a question of neighbourly compromise.
“From my view we do not really have a harmonisation problem regarding the legal provisions, but rather in terms of different national markets, nobody has the wish to give up,” VZBV nutriton scientist Angela Clausen told us.
“But it shows very clearly that we urgently need uniform clear distinction between (traditional) medicines and foods. This is especially true for the so far not regulated botanicals which are on the on-hold list.”
Warn vs ban
Joris Geelen, director of Food Law Consult, called the Belgian advice “quite bias” and said it was based largely on a 2014 report from the French Agency for Food, Environmental and Occupational Health and Safety (ANSES).
Instead of calling for a ban he said “appropriate and proportionate measures” should be taken on a case-by-case basis when a risk to public health was flagged for substances like botanical.
“Specific mandatory warning and reasonable maximal levels or a range can contain this risk without having to resort to extreme measures and forbid these ingredients.”
Last year the European Commission said it was considering the use of safety warnings on red yeast rice products.
The crux of the controversy
Red yeast rice has been an issue of some controversy in recent years in the EU.
MK, the active substance of the red mould grown on white rice, is chemically similar to the cholesterol drug lovastatin.
According to a 2011 opinion from EFSA, a 10 mg daily intake of MK is needed for a beneficial effect on cholesterol levels.
Geelen said it was not logical that EFSA authorised a claim before setting limits.
“I don’t say it’s always necessary, but in case when side effects are known, the safety assessment should be done first.”
Clausen said one of the main concerns was that consumers may take these supplements in addition to cholesterol-lowering medicine and underestimate any risks assuming ‘natural means safe’.
She also said dosages of red rice products could not be as accurately predicted as drugs.
The answer to this, Geelen said, could be a EU-level working group on botanicals to decide common assessment methods to track doses, a disparity highlighted in the French authority’s report.
“So a working group at the EC wouldn’t be a bad thing. The problem is that botanicals require a specific specialisation and expertise. And that’s lacking.
“Often [member state] experts have to deal with several subjects. So they can’t see the nuances needed for botanicals. And rather get rid of the problem (it’s a NF [novel food], it’s a medicine, it’s not scientific, it’s dangerous…).”
He said the current situation meant a “Bermuda triangle for supplements with botanicals” had formed.
If there was too little active substance, it couldn't win a health claim. If the dose was too high, it was classified as a medicine. If there was no record of use in the EU, it was considered novel.
Instead a new category with appropriate rules was needed, he said.