It's time to end EU’s botanical Babel, says expert

The problem with botanicals is just a matter of colliding cultures, industry interests and of process, says managing director for Italian-based Hylobates Consulting
The problem with botanicals is just a matter of colliding cultures, industry interests and of process, says managing director for Italian-based Hylobates Consulting

Related tags Food supplements European union

The EU is old enough and ugly enough to get itself out of its botanical rut, so what's the hold up? Dr Luca Bucchini, managing director of Hylobates Consulting, asks.

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…

Luca Bucchini Hylobates Consulting managing director
Previously Bucchini worked on the EC-funded project PlantLIBRA 

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.

Double standards?

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.

herbal botanical traditional medicine

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 Bucchiniworked on the European Commission-funded project PlantLIBRA (PLANT​ food supplements: L​evels of I​ntake, B​enefit and R​isk A​ssessment). 

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Quality is a priority for FS and herbal medicines, but not obstacle

Posted by Luca Bucchini,

Quality is a priority for both FS and herbal medicines, as data show. Do we need specific rules on botanicals in food supplements addressing quality? I totally agree.
But why would the quality standards for herbal medicines warrant their very favourable treatment in terms of claims? I can't see any good reason.

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It's not all about the claims

Posted by Aira,

Stating that there's no safety or consumer interest at stake is an understatement.

Marketing claims, which were here considered as the main issue in this article, are actually just a secondary debate.

Concentrated herbal products should have chemical controls and identity requirements more close to medicines than of foods. And regulators are wise to be cautious, especially what it comes to import from far-away countries. Not all harvest, collection and processing practices of the plants meet the level an European consumer would expect from a ready concentrate or pill on the herbal store shelf... and obviously our food regulations are not as strong as the medical regulations in controlling these type of risks.

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