Foods that offer consumers health benefits are the latest hot ticket for the industry. But difficulties in gaining approval for health claims could push this growing sector out of Europe. Emma Dorey investigates
Consumers want foods that will improve their health and food manufacturers want to supply them. But a spate of health claims being rejected by the European Food Safety Authority (EFSA) over products that claim to boost the immune system or aid dieting, for instance, has stopped industry in its tracks. And it has led some companies to claim the agency is overly rigorous in its approach to managing the labelling of so-called functional foods. EFSA acknowledges the need for further clarification about the scientific evidence needed to substantiate a specific claim – a complex process that must change, some say, if the industry is to stay in Europe and consumers are to benefit from healthful foods.
The EU regulation on nutrition and health
The EU regulation 1924/2006 on nutrition and health claims made on foods came into force in July 2007 to ensure that health claims on food products are backed by science – evidence that is verified by EFSA.
Before the EU law came into force, it was up to individual countries to assess claims, the plausibility of which was often accepted on the basis of experimental or observational studies. Such indicative evidence is no longer sufficient to support claims, which must now be proven by far more demanding clinical intervention trials showing an effect on a validated biomarker, says Patrick Coppens, secretary general of the European Responsible Nutrition Alliance.
However, it is almost impossible to demonstrate such things in some cases, he says. For example, EFSA has rejected a claim that glucosamine maintains joint health, but it is not clear how the claim could be proven with an intervention trial. ‘Nowhere is as rigorous,’ says Coppens. ‘The evidence requested is pharma-like.’
Many companies are frustrated at the lack of standard guidelines on what kind and amount of data are needed to establish cause and effect in an indisputable way. ‘The basic confusion about getting health claims approved in EFSA seems to be that there are no set requirements laid down by EFSA or the EU as to what is needed to substantiate a claim,’ says RV Venkatesh, managing director of herbal provider Gencor Pacific. ‘It seems to be a situation of all authority and no responsibility,’ he says, suggesting a lack of justifications and accountability about its decision-making process. Gencor has had its claim that Slimuluma could help control appetite and aid weight loss rejected by EFSA.
‘Unscientific and impossible results are being requested from products supported by peer reviewed and published clinicals also, which directly contradict other peer reviewed and published science,’ says Venkatesh. ‘It’s almost as if, using their mandate, they seem to ask for any end result from any study, even though the study was not designed for that end result and then they use that as an excuse to reject claims.’
Others disagree. ‘The EFSA evaluation is perfectly middle-of-the-road science. Most panels of independent experts would reach the same conclusions, although one can always quarrel about individual cases,’ argues Martijn Katan, from the department of health sciences at VU University Amsterdam in the Netherlands. ‘Having a scientific publication that supports a claim means very little. Scientific journals publish lots of studies with unusual, incomplete or less relevant findings because in the end the chaff will separate itself out, and journals do not want to block publication of anything that might turn out important later. But proving that a food really enhances well-being or health in humans is another matter.’
‘Large companies know what evidence is required to prove that something works – their protestations are just part of the game,’ adds Katan. ‘Small companies may not realise how science works, and they are understandably upset that they can no longer claim or intimate health benefits without proper proof.’
Indeed, Unilever supports EFSA’s claims process, says Paul Matthews, a spokesperson for the multinational giant. Matthews says it is clear that the scientific standard has been set high for nutrition and health claims in the EU, but it provides harmonisation of scientifically substantiated nutrition and health claims across the industry. Matthews points out that Unilever has a strong track record on the approval of its key nutrition and health claims.
However, Connie Hersch, director for health affairs at dairy company Danone, says the complex regulatory process is demanding for all parties involved – including EFSA – and needs further clarification. Danone has withdrawn claims that its yoghurt Activia aids digestion and that its probiotic drink Actimel strengthen’s the body’s defences.
The current confusion could have detrimental effects on the industry. With only a handful of EFSA templates and briefing documents to consult, smaller companies in particular may not be able to afford the time and expertise it takes to conduct the studies necessary to support their claims.
Moreover, EFSA’s evaluations may decrease industry’s investment in the development of functional foods, because, in future, functional foods will really need to work, adds Katan. ‘The investments needed to develop new foods that really improve health are huge and cannot be recovered for lack of patent protection, so industries are reluctant to invest in this,’ he says.
As a result, a lot of companies are reflecting very carefully whether it is still economically viable to invest in the development of functional foods, Coppens says. ‘It is not illogical that some companies will be pushed outside Europe,’ he says, pointing out that a lot of research on genetic modification has moved away from the EU to other parts of the world with less restricitve rules (C&I 2008, 3, 5).
Katan disagrees saying, ‘Companies can sell their foods with poorly substantiated health claims outside Europe, and legal loopholes may arise in the EU. This thing is not over.’
A lack of healthful foods in Europe could, Venkatesh suggests, ultimately result in higher healthcare burdens for EU member states. ‘Right now, junk foods seem to get a free rein and beneficial foods are being shot down.’
Meanwhile, Lucia De Luca, EFSA spokesperson, points out that the regulatory body simply works within the EU regulation, which is clear in its requirements for scientific evidence to support health claims. ‘Criteria for pharma is much, much tougher,’ she argues, adding that EFSA’s criteria are in line with those of the World Health Organization, Codex Alimentarius and the US Food and Drug Administration. ‘The complex requirements for food claims are very exhaustive, but it’s a regulation that we must comply with,’ she says.
Nevertheless, acutely aware of the need to develop clearer guidance, EFSA is planning more focused and specialised meetings with industry on specific groups of claims associated with particular ingredients to continue to clarify what kind of scientific evidence is needed in particular areas. The first, scheduled near the end of 2010, will be on claims concerning gut and immune health.
The meetings, designed to improve interaction with industry, are welcomed by both Unilever and Danone. Even Gencor’s Venkatesh is optimistic: ‘Gencor will continue to develop functional foods in various world markets and that would include Europe,’ he says. ‘We believe that in the long term good science will prevail.’
Staking a claim on health: the ins and outs of EU regulation
A company wishing to make a health claim on a food product must submit a dossier of supporting scientific evidence to EFSA for verification. This applies to any direct, implied, vague and non-specific claims on all labelling and advertising. After assessing the evidence, EFSA makes a recommendation to the Commission, which must then decide whether to approve or reject the claim.
‘To carry out a scientific evaluation of the health claim, the relationship between the benefit claimed and the substance or product has to be clear,’ says De Luca.
‘General function’ health claims – such as ‘calcium is good for your bones’ – are based on generally accepted scientific evidence and are defined by article 13.1 of the regulation. As of May 2010, EFSA had assessed around 900 of the 4637 claims submitted, giving the go ahead for a fifth of them, subject to Commission approval.
‘New function’ health claims or claims regarding child development or health and disease risk reduction, such as ‘this product reduces cholesterol’, require applicants to provide scientific evidence substantiating the claim proposed for a specific product or substance. Such claims that are based on new scientific evidence and/or for which protection of proprietary data is requested come under article 13.5, while those regarding disease risk reduction and child development or health come under article 14. Of the 304 applications received, EFSA has evaluated 92 and 51 have been withdrawn. Of the remaining 41, a fifth have been approved.
Emma Dorey is a freelance writer based in Brighton, UK.