Health-benefit claims for Europe’s foods must at last be substantiated by science.
Will a daily probiotic yogurt improve your immune defences? And will cooking with olive oil boost the levels of ‘good’ cholesterol in your blood?
So far, the food companies behind these particular claims have not supplied the hard scientific evidence to convince expert committees of the European Food Safety Authority (EFSA) in Parma, Italy, that they are warranted. European Union (EU) legislation means that all similarly unsubstantiated health claims for food will soon be disallowed. A register of permissible claims — which will be regularly updated whenever new scientific evidence can be brought to bear — will be presented to the European Parliament for inspection next month, and adopted by member states later this year. Already, many health-food companies, wary of possible litigation, have toned down their marketing claims.
The regulations, drafted by the European Commission and adopted by the EU in 2007, are intended to put an end to the free ride that the food and food-supplement industries have enjoyed until now. Companies will no longer be able to market their products with unproven promises that consumers will be healthier, slimmer or have happier lives. Even the words ‘probiotic’ and ‘antioxidant’ will disappear from food and food-supplement labels in the absence of confirmed specific health benefits.
To implement the regulations, the EFSA — whose role is to supply scientific advice in support of EU policies — set about drawing up a register of permitted health claims for food ingredients, asking its expert committees to recommend for inclusion only those for which the claims have been unambiguously proven in healthy populations.
Of the 2,927 consolidated health claims for different ingredients examined by the EFSA, only 241 passed muster. A second chance was given to 91 of the non-approved claims, 74 of which related to microorganisms — pre- and probiotics. But the EFSA rejected all of the resubmitted dossiers except two: prunes for normal bowel function and the polysaccharide α-cyclodextrin, a soluble dietary fibre, for limiting the rise in blood glucose after a meal.
The high rejection rate dismayed sections of the multibillion-euro health-food industry, which has lobbied fiercely against this legislation with disingenuous arguments that it inappropriately applies pharmaceutical standards to foods. In fact, it is the industry that has tried to make pharmaceutical-level claims for its products while bypassing medical-registration procedures and costly quality control.
Already, many health-food companies, wary of possible litigation, have toned down their marketing claims.
But there is an elephant in the room: botanicals. Around 2,000 health claims for plant-based foods are on hold at the ESFA as manufacturers plead for special treatment. The manufacturers refer to the 2001 EU medicines directive which allowed traditional herbal medicines a simplified registration procedure not requiring rigorous proof of efficacy. The EU health commissioner must decide whether plant-based products marketed as health-promoting foods should be treated with similar leniency, but the decision has been shamefully delayed. The new commissioner, Tonio Borg, has been in office for only a few weeks, but he needs to bring clarity quickly — and to firmly reject moves to weaken requirements for scientific evidence.
The European Court of Justice may yet force a decision on the commission if it continues to prevaricate. The court is currently hearing three cases of unfair competition from manufacturers stopped from making claims on non-botanical food and food supplements. Yogurt manufacturers, for example, do not consider it fair that botanicals can continue to be marketed with unproven claims of improving immune defences when they are no longer allowed to do so.
Faced with the new legislation, the yogurt industry has in fact buckled down to generate the scientific evidence that the commission wants. Manufacturers have joined forces to produce a meta-analysis of published evidence on some probiotic strains to try to get at least some claims onto the permitted list before it circulates to parliament. And they are also launching double-blinded clinical studies to prove that certain microbial strains have particular effects on health. That is an expensive exercise, but it is the price that must be paid by those who want to stay in the game.
Related links in Nature Research
Diversity, stability and resilience of the human gut microbiota 2012-Sep-12
Microbiology: Categorize probiotics to speed research 2012-May-23
Microbiome: Gut reaction 2011-Nov-23
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Culture shock. Nature 493, 133–134 (2013). https://doi.org/10.1038/493133b