Many European citizens fret that the European Union has too much power. So, they might be surprised to know that a food supplement with plants (botanicals) which they happily bought off the shelf in the UK may be regarded as an unauthorised, potentially dangerous medicine in Germany.
They may also be dismayed to find a trusted local organic maker of something like primrose supplements would need to spend significant amounts of money to discover the most current attitudes of each 28 member states on botanicals (and even then it might not find the answer).
Surely, in 58 years, the EU must have at least made sure that safe food supplements with plants could be sold anywhere in Europe?
The answer is an embarrassing no. The EU has regulated the size of whole fruits and to some extent even restaurant menus. But it can’t agree on whether exposing German or Danish consumers to garlic in food supplements is a reckless activity that only the French, Italians or Brits would undertake.
In fact, there is no safety or consumer interest at stake. Consumers have an interest in having a marketplace with as many safe, quality and varied products as possible, with the on-pack information needed to choose. They also have a stake in a prosperous economy. It’s just a matter of colliding cultures, industry interests and of process.
List after list after list after…
Though there is no doubt that agreeing on a list of safe plants, with a history of use in Europe, is not an easy task.
Belgium, France and Italy have proposed a list, the famous 1000-plant strong BELFRIT. Beyond this, Romania was rumoured to be close to adopting BELFRIT. Yet this year it announced a 2647-strong list instead because apparently BELFRIT was too short for some of those involved in the drafting.
Germany has done some great work putting together yet another list. Yet this did not provide as much legal clarity as business crave. This shows how difficult it is to agree on a list, within and among countries.
However, the EU knows how to go about these things. You need to put science first, comply with the principles of EU law and get down to work. We have shared lists of food additives, feed additives, vitamins and minerals, flavourings, health claims and many more.
Herbs for medicinal use have been assessed for safety by the European Medicines Agency (EMA) – often the very same as those used in food supplements – and the effort requested of industry has not been too great. Almost everyone agrees that, with the influx of botanicals and herbs from East Asia, we can sort out safety quickly and put down on paper strong rules on the quality of botanicals – which is the priority.
So what are the stumbling blocks? Why can’t a Yorkshire SME sell its plants to a Finnish herbal shop by just checking a shared regulation? The answer is mainly health claims. The European Food Safety Authority decided (reasonably) that textbook evidence was sufficient for vitamins and minerals, but not for botanicals – the resulting blank packages have not helped. So, some now argue that tradition and in vitro evidence are sufficient to back some type of claims, and such claims would not mislead consumers.
Last week the European Consumer Organisation (BEUC) spoke strongly against this idea. Fair enough. But is BEUC going to launch an assault on traditional herbal medicines as well that, thanks to 2004 legislation, can be sold as actual medicines based on the same type of evidence i.e. tradition and ’plausibility’? Is this not a potentially more serious issue for consumers? Opponents of tradition-based claims should check that piece of legislation as they take arms against tradition claims on botanical food supplements.
Again, science can help. We now have a growing body of evidence on how consumers react to tradition-based claims, developed by the likes of Dr Monique Raats at the University of Surrey and Dr Klaus Grunert at the Aarhus University.
Generic descriptors back tradition-based claims
By permitting generic descriptors, the EU has also recognised that tradition-based claims are not necessarily misleading. Surely, with the help of science, rules on such messages could be crafted so that consumers understand they are dealing with tradition and not modern science. At the same time, why not give a reasonable time frame and appropriate guidance from EFSA for the industry to develop the evidence for claims which tradition alone can’t back?
Arguments seem to also surround the food/medicine borderline. Is this problem too hard to solve? Not really. If mandatory lists are not possible, guidelines on problem plants can be issued. And EU member states have agreed to vote on controversial foods for medicinal use. Can’t the same approach be used in this case too?
If the EU agreed on a common list, industry would gain 500 million customers – which would be beneficial for smaller companies with limited regulatory budgets.
To put things in perspective, local industry in China or India both have internal markets of a billion+ people
How to go about it? It’s simple really: Put safety and consumers’ interests first and next do what is best for Europe’s economy. Off the shelf solutions are readily available in the EU’s 60-year-old harmonisation tricks bookshelf.
Luca Bucchini, PhD, MPH is managing director for Italian-based Hylobates Consulting. Previously Bucchini worked on the European Commission-funded project PlantLIBRA (PLANT food supplements: Levels of Intake, Benefit and Risk Assessment).