Some 80% of food and drink health claims have now been turned down by the European Food Safety Authority. Why, asks Hannah Stodell

EU health food claims are causing food and drink manufacturers serious gut-ache.

After already issuing a swathe of rejections, European Food Safety Authority scientists dealt another blow this month, turning down more claims in the fourth batch of proposed ‘general function’ health claims for food and drink products.

For example, taurine used in many energy drinks, including Red Bull cannot now claim to delay the onset of fatigue. And claims over the benefits of wholegrain in improving gut health and bowel function were rejected on the basis that they were “not sufficiently characterised”. In other words, the claims were simply too woolly.

And while these rejections were offset by victories for sugar-free chewing gum and caffeine, the number of rejected claims is nothing short of astonishing.

Member states have together submitted more than 44,000 health claims since the start of the process and these have been boiled down to 4,637 claims for consideration by EFSA. Of these, the majority an estimated 80% have been turned down.

A final batch of 600 is set to be evaluated by EFSA by June for publication in the autumn while so-called ‘botanical claims’ have been placed on hold at the request of the European Commission. But the pattern is now well established. EFSA scientists are going to kick out almost all the claims.

News of the high rejection rate is a huge blow to food and drink manufacturers and retailers, and potentially to the economy as a whole. So how has this happened and where now for companies who have had their claims refused?

Some believe the industry is to blame. “Large sections of the industry didn’t really understand the level of scientific evidence that would be required,” says Owen Warnock, partner at law firm Eversheds. “The blame lies with the manufacturers and their technical people for not thinking carefully about whether they had proved what needed to be proved.”

BRC deputy food policy director Andrea Martinez-Inchausti blames insufficient dialogue between EFSA scientists and the wider industry. “If we had been given guidance and more precise information about the nature of information they needed to be able to assess the claim, we would not be in this situation,” she says.

After EFSA rejected the claimed immune benefits of probiotic drinks and yoghurts last October, suppliers from the lucrative industry were up in arms and met with EFSA scientists two months later at a ‘gut and immune health workshop’ to thrash out a clearer framework for submissions.

However, they are still scratching their heads over what is required. “[The relationship with EFSA] is better than it was but it wasn’t a very satisfactory discussion or one that gave us the confidence to know what to do to get a positive opinion,” says Martinez-Inchausti.

Danone, which withdrew its ­application for claims relating to its probiotic Actimel and Activia brands last April, still isn’t able to say what it will do next. And smaller companies like Higher Nature, a nutritional supplements business based in East Sussex, are meanwhile trying hard to find new ways of marketing ingredients against the regulatory backdrop. “There are a lot of grey areas, which haven’t been helpful. Where one has had to take a decision on what is reasonable and what is not, we have ­taken the safest route,” says CEO David Coulson.

Mounting concern
Other parties are even more critical. Amid “mounting concern” from the scientific community over the way information has been compiled and presented, the European Federation of Associations of Health Product Manufacturers (EHPM) has called for a fundamental reappraisal of EFSA’s claims process which could threaten the system’s credibility.

It also questions EFSA’s almost exclusive reliance on randomised controlled trials and says its interpretation of the claims legislation was “unduly restrictive”, making it impossible to acknowledge and ­assess a number of health effects.

Another reason for the troubles is a subtle alteration from the aims of the original legislation, claims Melanie Leech, director general of the Food & Drink Federation. The Nutrition and Health Claims Regulation was launched, in 2006, to protect consumers against “unsubstantiated, exaggerated or untruthful claims about foodstuffs”.

But not only has the timeline slipped, the goalposts have moved, she says. “The objectives were entirely appropriate and laudable but several years later they also want the legislation to deliver a whole set of communications to get ­consumers to be more informed about their choices.

“There’s a huge gap between what they started off wanting to achieve and the impact of the ­legislation we’re ending up with.”

What next?
Manufacturers have six months to phase out rejected health claims unless they have been turned down on grounds of “insufficient evidence”, in which case they may qualify for a ‘second chance’ reassessment and groups such as the FDF and the EHPM are lobbying hard to secure this.

“We strongly believe a number of rejections are not justified,” says EHPM chairman Peter Van Doorn. “In many cases a full consideration of the totality of the evidence and an approach based on nutritional science would be able to arrive at more differentiated conclusions as a basis for the possible acceptance of certain claims.”

However, Martinez-Inchausti warns this could be too little too late for some claims hoping to make it on to EFSA’s final list of positive opinions, which is expected to be published by early next year. “We’re going to end up with a limited positive list because a lot of the claims haven’t even been looked at or assessed not necessarily because there is a lack of ­evidence, but because categories may not have been adequately ­defined,” she says.

And the wrangling has only just begun, cautions Warnock. “Once EFSA draws up a final list of positive claims, more and more companies will start comparing one claim with another to see whether rulings have been consistent the ­debate is set to run and run.”

Key winners and losers from EFSA’s batch 4

Claims approved:
- sugar-free chewing gum with fluoride protects tooth enamel and helps restore vitamins in teeth
- replacing digestible starch (eg in processed cereal and grain products) with resistant starch (eg in wholegrains, legumes, pasta) helps regulate blood sugar levels which could benefit Type 2 diabetes sufferers.
- walnuts (at least 30g consumed daily) help improve blood vessels. Caffeine increases alertness and attention (at least 75mg per serving)
- meat or fish (at least 50g) improve iron absorption, which is essential to red blood cells. Water helps physical and mental activity and maintains the body’s normal temperature (when two litres are consumed daily)

Claims rejected:
- wholegrain does not help gut and bowel health EFSA ruled claims were not “sufficiently characterised”.
- almonds and walnuts help manage cholesterol levels but not beyond what could be expected from their fatty acid composition. Almonds don’t benefit erectile function
- taurine - commonly used in energy drinks - doesn’t ward off tiredness during exercise
- sugar beet does not help manage blood sugar levels
- charcoal does not reduce bloating
- beta-carotene (found in foods such as sweet potatoes, carrots, kale, spinach) does not protect skin from UV damage