The EFSA has assessed the first batch of health claims - and rejected a massive 70%. Where next for those that have lost out, asks Nick Hughes


Thursday 1 October 2009 marked a seminal day for the food industry. More than three years after the EU first declared its intention to examine the veracity of health claims made by the producers of food products and food components, the first wave of opinions landed. The news wasn't good.

The European Food Safety Authority's (EFSA) evaluation of the first tranche of 523 'general function' health claims (out of 4,185) produced a raft of negative verdicts. Just 30% of claims were given the thumbs up by EFSA and these results will be used by the European Commission to decide which ones to ban under its Health and Nutrition Claims regulation.

Several claims that got the thumbs up related to components such as dietary fibres, fatty acids and sugar-free gum. Submissions linking probiotic bacteria with improved gut health, omega-3 with maintaining healthy cholesterol levels and taurine with enhanced physical performance are among those that failed to make the grade.

It is a major blow for producers of omega-3 enriched foods and energy drinks, but for probiotics in particular it's a setback. Categories such as the £220m dairy shots sector have been built on claims that probiotics boost the immune system or improve gut health.

In reality however, only 10 claims for probiotics were rejected outright with a further 170 dismissed because of their failure to characterise the substance in question. And it's here that the battle lines have been drawn between EFSA and manufacturers.

The latter claim EFSA failed to set out clear guidelines for applicants. "We've been left with a situation where people have done the best they can with what they thought they were being asked for, but it turns out that wasn't quite what EFSA wanted," says one industry source. "There is a lack of transparency in the process."

EFSA has demanded a high standard of scientific substantiation for claims, rejecting many submissions where there are insufficient clinical studies to establish a cause-and-effect relationship between the food and the claim.

Some experts, however, believe the bar for scientific evidence has been set unrealistically high. "It is not prudent to expect a level of efficacy for probiotic foods equivalent to what is required for pharmaceutical agents," says a spokesman for the International Scientific Association for Probiotics and Prebiotics. "The fact some dossiers were rejected should not be interpreted to mean there are no substantiated probiotics, nor that products with rejected strains have not been shown to provide health benefits."

The fear for the probiotics industry is that EFSA's negative opinions will filter through to the public without being placed in context. It's plausible that the first batch of probiotic claims were poorly conceived dossiers from niche domestic players, say experts. Indeed, Danone and Yakult are reported to have withdrawn initial dossiers on their yoghurt drinks and resubmitted claims for specific, well-characterised probiotic strains that have yet to be assessed.

Positives for probiotics?
"We still don't know which member states put forward these claims and indeed which interested parties gave the supporting evidence," says FDF director of safety and science Helen Munday. "If these are the most difficult claims to prove and they were the least likely to succeed, you've now got some negative publicity out there. It's quite possible in the next tranche that you're going to have some positives for probiotics."

The biggest winners in the first tranche of verdicts were vitamins and minerals, with EFSA supporting long-established links between, for example, calcium and bone health. The industry source says it's little surprise that vitamins and minerals have benefited.

"The process EFSA has developed works very well for very simple constituents, such as calcium and Vitamin D, where it's really not hard to define what you're talking about," says the source. "Where we suspected the process wouldn't work so well is where you're defining a complex food made up of lots of different components. The danger is that some of the time claims are going to be discounted because they don't conform closely enough to what EFSA would see as the ideal scientific process."

Not all experts are sympathetic to the industry's protests. "A lot of the claims that were put in were massively vague and not supported by decent science," says Owen Warnock, partner and food law expert at law firm Eversheds. One industry source agrees some of the submissions were "laughable", citing one supplement that claimed to enhance women's breasts. He maintains, however, that a large number of claims were let down by the confusion over EFSA's requirements and believes some submissions will only need tweaking to be approved.

Better supporting science
Warnock, too, believes that a lot of rejected claims will eventually be accepted once they are supported by more compelling scientific evidence. "The big multinationals have plenty of resource," he says. "If they think there's going to be a real advantage in having brands or sub-brands that make health claims, then they'll invest the money to make sure they get the case approved."

Either way, the prospect of companies having to remove unsubstantiated claims is a long way off. This is only the first batch in more than 4,000 claims that have to be assessed by EFSA. It is not expected to finish its work until well into 2010, after which it will present its findings to Brussels and member states who will draw up a definitive list of approved claims, expected some time in 2011.

In the short term, manufacturers who disagree with EFSA's verdict will look to resubmit claims with more compelling scientific evidence. Should their claims still fail to make the cut, there is one remaining option. "The other possibility is to see if some kind of legal challenge can be launched, claiming the decision of the EFSA is sufficiently illogical and not legal under the nutrition and health claims regulation," says Warnock.

However, Munday argues that there is unlikely to be much appetite in the industry for legal challenges and Warnock concedes it would be a high-risk strategy. "It would be a very difficult thing for manufacturers," he says. "It would be expensive, very uncertain in its outcome and potentially sour its relationship with EFSA and certain parts of the European Commission."

For the time being, diplomacy is the order of the day for health claimants, but EFSA will find the industry in a far more combative mood if it fails to deliver a more transparent approvals process.