Back in December 2006 the adoption of an EU Regulation governing nutrition and health claims made for foods was broadly welcomed by a food industry investing large amounts of money in developing ‘functional food’ products. The Regulation promised to benefit consumers by ensuring that health claims made on labels were based on scientific evidence and did not mislead. Businesses would also benefit from the creation of a level playing field allowing accepted claims to be used right across the EU. Unfortunately the implementation of the Regulation has proved anything but welcome for the industry. With EFSA rejecting the majority of claims outright, the assessment process has been seen as a threat to the very existence of a functional foods market in Europe. Now that the first stage of the process is complete, are the future prospects for health claims on foods really so bleak?

The term ‘functional food’ first appeared in Japan in the 1980s. Of course, all food is functional to some degree, but the term was coined to describe products that could deliver health benefits or help to prevent disease in addition to their nutritional value. Since that time the food industry has identified functional food products as a key growth area providing significant opportunities to add value to food commodities through fortification with functional ingredients. This has led to a proliferation of new products being marketed for their positive effects on health and well-being, or their potential to prevent disease. The market grew rapidly and continues to do so. A 2010 report by Global Industry Analysts Inc. estimated that the global market for nutraceuticals (functional foods plus dietary supplements) will be worth no less that US$243 billion by 2015, driven largely by growth in the USA, Europe and Japan. It is the functional foods market that is predicted to grow most rapidly as the supplements market matures. It is therefore not surprising that many food manufacturers have turned their attention to functional foods over the last ten years or so, with the promise of healthy profits.

A need for regulation

The key to successful marketing of a functional food is the development of a clear message for the consumer to convey exactly what health benefits they might expect to gain from the product. For example, if the food contains an ingredient that can be shown to have a positive effect on gut health, the label must say so, preferably in a succinct and eye-catching phrase. Such ‘health claims’ began to appear in increasing numbers on food labels and, while many were reasonable and based on sound evidence, others were vague, speculative, or even downright misleading. Since there was no mechanism in Europe to regulate health claims, there was a growing risk that some less than scrupulous food manufacturers might make unjustified claims in order to boost profits. Clearly, regulation was needed and, after the usual consultation process, the European Parliament and Council of Ministers adopted Regulation (EC) No 1924/2006 on Nutrition and Health Claims made on Foods (the NHCR) in December 2006. The stated purpose of the Regulation was to, "…protect consumers from misleading nutrition and health claims – ensuring that claims are truthful, clear, reliable and useful for the consumer when making healthier food choices, to provide a clear and level playing field for economic operators and to ensure the free circulation of foods bearing claims." The key to achieving that aim was to ensure that all health claims would be based on and supported by scientific evidence. At the time, industry and other stakeholders broadly accepted this principle.

Once the Regulation was in place, a process for implementing it was outlined. As the main source of scientific expertise for food within the EU, the European Food Safety Authority (EFSA) was appointed to the task of evaluating health claims to ensure they complied with the requirements of the NHCR, and it fell to the Authority’s Panel on Dietetic Products, Nutrition and Allergies (NDA) to carry out the assessment process. Most existing and proposed health claims for food fell into the category of "general function" claims under article 13.1 of the NHCR. This covers claims that "…refer to the role of a nutrient or substance in growth, development and body functions: psychological and behavioural functions: slimming and weight control, satiety or reduction of available energy from the diet." To have a claim considered under article 13.1, food manufacturers were first required to submit their claims, along with supporting evidence, to their national authorities, which would then forward them to the European Commission. Between July 2008 and March 2010 the Commission received a rather startling 44,000 health claims submitted by Member States for evaluation. A preliminary screening process whittled the number down to just over 4,600, but the NDA Panel was still faced with a herculean task. They began work in October 2008 and eventually completed the evaluation process in July 2011. By then they had assessed approximately 2,760 claims (1,550 claims relating to ‘botanicals’ were separated from the initial evaluation by the Commission for later consideration and 330 more were withdrawn).

A shock in store

Many of the general function claims submitted for evaluation by the NDA Panel had been present on the labels of established products for some years without problems. The manufacturers of those products might have thought that their claims would be accepted almost as a formality, but they were to be sadly mistaken. When the Panel published its opinions on the first batch of claims in October 2009 the results sent a shock wave through the functional foods industry. Around two thirds of 523 claims relating to over 200 foods were rejected. This was unexpected to say the least, and caused outrage among manufacturers and researchers, but it set the pattern for what was to follow. By the time the Panel published the sixth and last batch of opinions in July 2011, approximately 80% of the 2,760 claims evaluated had been rejected. Particularly badly hit were probiotics, where virtually all the claims made were rejected. Once it became apparent that the Panel were very likely to reject claims for probiotics, major manufacturers like Danone withdrew claims for some of their biggest selling products from the evaluation process.

The industry reaction to the outcome of the claims assessment process has been an understandably angry one. Products that have been on sale for years bearing a health claim that has been rejected may now have to be reformulated, with redesigned packaging and revised labels. Removing the health message compromises current marketing strategies and threatens to depress sales in the long term. Some manufacturers have stated that they may withdraw products from sale if they can no longer use health claims. There have also been numerous complaints over the process itself. For example, in 2008 the European Commission published guidance on claims evaluation. This made it clear that the accompanying dossier of scientific evidence supporting a claim should contain data from human clinical trials. Since such trials can take two or three years to complete, it was already too late for claims that were in the submission pipeline. This led to a broader complaint that EFSA had taken an approach to evaluating the claims that would be more suited to pharmaceutical products, where the standards of evidence are necessarily high. Manufacturers pointed out that functional foods are meant, unlike prescription drugs, to benefit healthy consumers and should not be assessed as if they were drugs targeting a specific illness. It is a widely held view in the industry that EFSA should have considered the "totality of evidence", rather than focusing on clinical trials data. But the main complaint related to a lack of communication between EFSA and the industry and insufficient transparency regarding the evaluation process. The Authority attempted to address this by staging workshops for applicants during the process, but by then the damage had largely been done.

The research community also reacted strongly to the rejection of so many health claims, especially those working in the field of probiotics. A group of European scientists working in the academic research sector set up a web site, www.gut-health.eu, on which they invited researchers to sign a statement expressing their concerns about the assessment of health claims. The group feared that a lack of clarity about the scientific evidence required to support claims could seriously damage research and lead to promising health applications not being submitted for claims approval. They were also concerned that the current approval process as set out in the NHCR is too strict and does not allow the totality of the science to be included in the assessment.

What went wrong?

But why were so many of the health claims submitted rejected by the NDA Panel and what can be learnt from the claims that were successful? A number of reasons were given for rejecting claims, but many of the applications included common faults that inevitably led to rejection. One was a failure to properly identify the substance for which the claim was being made. This was a common problem with probiotic bacteria, where the strain referred to needed to be properly characterised by genotype to avoid confusion. In some cases this had not been done, leaving the Panel no alternative but to reject the claim immediately without even considering the scientific evidence in the supporting dossier. EFSA says that other "information gaps" were also common reasons for rejection. These included, "the lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of body functions; or the lack of precision regarding the health claim being made." Some of the submitted claims were also found to fall outside the scope of the NHCR. In other words, many claims were rejected because the accompanying dossier was inadequate, rather than because there was insufficient scientific evidence to support the claim. Members of the NDA Panel have also criticised the overall quality of some applications. It is even alleged that some contained supporting "references" sourced from Wikipedia, or trade association press releases. Although some health claims were rejected because of insufficient evidence for a cause and effect relationship, many more were victims of the apparent mismatch between what EFSA expected to find in dossiers and what manufacturers thought was required.

Nevertheless there were some successes. Many of the 20% of successful applications related to vitamins and minerals, where the supporting evidence is clear and well documented. But other successful claims included a positive relationship between melatonin and sleep, the positive effect of certain dietary fibres on blood cholesterol levels and the link between reduced sodium and healthy blood pressure. These positive outcomes at least show that it is possible to provide the scientific evidence needed to support a successful claim.

What happens next?

By the end of 2011, the European Commission intends to present a list of permitted Article 13 health claims, which will then come into force in 2012. The list will not include the 1,550 claims relating to botanicals that were removed from the initial evaluation process. The Commission has yet to decide how these should be dealt with, partly because the NHCR apparently requires a higher standard of scientific evidence backing health claims than is needed for the approval of certain herbal medicines – an anomaly that clearly needs to be resolved. The permitted claims list will be adopted in a single step rather than phased, as was the case with the approval process. The fear among functional food manufacturers and researchers is that claims that do not make it onto the list will be lost forever, potentially depriving consumers of products that convey real health benefits.

However, the Commission has provided a lifeline to some manufacturers whose claims have been rejected. Back in September 2010 it announced that some of the claims already considered "…would benefit from a further assessment process." In effect, applicants whose claims had been rejected because of insufficient characterisation of a microorganism, or because there was insufficient data provided to establish a cause and effect relationship between the food and the claimed effect, were invited to resubmit their claims during the period from 1 June to 30 September 2011. This provides a second chance, particularly for probiotic claims that were not fully evaluated because the probiotic strain involved was not fully identified. EFSA expects to receive any claims submitted for re-evaluation before the end of the year, and a timetable for the process will then be drawn up. At present there seems to be no prospect of any further concessions for unsuccessful applicants. The Commission has pronounced itself, "…satisfied that EFSA’s assessments are consistent with the requirements set out in the Regulation," and does not foresee any further adjustments to the process.

Meanwhile, the nutraceutical and functional foods industry has begun a lobbying campaign aimed at raising awareness of how the evaluation of health claims has been progressing and the possible implications for business and for employment. For instance, a recent press release from food supplements trade body EHPM* commented that, "Increased barriers to trade and less consumer choice will be the likely effect on the food supplement market if the European Food Safety Authority’s (EFSA) article 13.1 claims evaluations become law." Lobbying activity over the next few months is likely to focus on MEPs, who will eventually be asked to consider whether the Commission’s list of permitted Article 13 health claims should be adopted. Until the list has been finalised by the Commission and adopted by the European Parliament and the Council, it will not come into force. Some industry insiders believe that there may yet be significant changes before that happens.

Looking at this whole sorry saga from the adoption of the NHCR in 2006 until now, one key point leaps out at the interested observer. The problems and controversies that have developed as the claims evaluation process has gone on all seem to have their roots in a lack of communication. Too many assumptions have been made by industry and too little timely information has been provided by the Commission and by EFSA. While attempts have been made to put this right, there is still an apparent disparity in how the two sides see the claims evaluation process and how it should work. For industry, the way forward seems clear, if unwelcome. Unless the NHCR can be amended, which looks unlikely at present, more resources will have to be directed at generating scientific evidence to support future claims. There is enough guidance now available to make sure that a supporting dossier contains all the data needed to establish the cause and effect relationship between product and claim. Industry can only bite the bullet, spend more on the science, and build a cast iron case to support a health claim. Unfortunately, that may not be an option for many smaller businesses, although it is worth remembering that anyone will be able to use a permitted general function health claim if it applies to the product concerned. The claim does not have to be evaluated for every product on which it appears.

Overall it appears that, while the evaluation of health claims can hardly be called an unqualified success, neither should it be considered a total disaster. The Commission decision to allow resubmission of certain rejected claims reveals that there is some scope for compromise. The point of the NHCR remains primarily to protect the consumer, not to penalise the European functional foods industry.

* European Federation of Associations of Health Product Manufacturers