Guidelines as to what industry needs to do in order to get a health claim approved have, so far, been as clear as mud. Now, as the massive nature of the task dawns on the authority, both industry and consumers may find themselves the losers to a set of regulations originally conceived to help both. The two pinions of article 13 (regulation 1924/2006), which governs any food claims relating to a role of a nutrient, must be "based on generally accepted scientific evidence" and be "well understood by the average consumer." As practical implementation comes closer, the vagaries built into the original text need to be cleared up. But although the European Food Safety Authority (EFSA) is in charge of scoping out the science attached to the health claims, it has not made it clear what it wants from industry in the way of evidence. The problem is that science is always subjective, and what may be accepted by one scientific school of thought, may not be accepted by another. As a result industry is preparing to bombard EFSA with thousands of proposals. Clearly businesses - in the wake of massive uncertainty - are left guessing what they need to include, and have submitted as much as possible to avoid missing out. These submissions from industry go to Member State regulators, who have until the end of the year to screen the claims they receive. Already the UK is looking at some 2,000 claims and Finland more than 600. Other countries are thought to have received as many as 4,000. EFSA has already said it will struggle if it receives an onslaught all at once. It does not have limitless resources to sift through the claims, which it has to do by the beginning of 2010. Currently the panel charged with doing so has just 11 members - although there is an option to bring in more. Basil Mathioudakis, head of food law, nutrition and labelling at the Commission has already said he was "concerned" over the number of claims coming forward. Not a comment that fills anyone full of confidence. Another major point of the 1924/2006 regulation is that nutrition and health claims must be for consumers' benefit - so the shopper knows exactly what a food is supposed to do for them. Article 13's criterion for a claim to be understood by the average consumer is also mired in haziness. What is an average consumer? How will their understanding be judged? To date there is no provision for evaluating how a consumer understands a health claim. And more worrying, while EFSA and other regulatory bodies have acknowledged a need for this, no one had come forward with how this can be done. Perhaps we can let EFSA off the hook here. After all, its remit is science, not consumer intelligence. But just who IS going to step up to the plate and tell us what's what? The time has come to stop passing the buck, or suffer the consequences. In the US, their version of health claims was introduced a couple of years ago and was too beset by delays. Despite pledging that a response would be given to all claims submitted within 365 days, the Food and Drug Administration (FDA) has exceeded this timeframe on a number of occasions. In one case the FDA was more than 300 days over an original deadline for approval. If EFSA and the Commission to which it answers, are not careful to issue instructions - clearly, and without further delay - they will find themselves in a similar situation. And the ultimate casualties of regulation that is not doing what it says on the tin will be consumer safety and industry innovation.
Alex McNally is a senior reporter with NutraIngredients.com and has lived and worked in France, Brussels and the UK. If you would like to comment on the piece, send an email to: firstname.lastname@example.org