Mountains of effort have been invested by the functional-foods and ingredients industries into pushing for changes to the European Nutrition & Health Claims Regulation.
Time and again, however, the European Food Safety Authority — which is responsible for the assessment of claims — has refused to yield to calls to relax the stringent criteria it is applying to dossiers. This means that while headlines are dominated by appeals for reform, behind the scenes companies that wish to continue making health claims for their products have had no choice but to quietly get on with preparing for the new regulatory environment.
This has created a whole new revenue stream for a select group of companies capable of providing the specific understanding and services food businesses require to navigate the regulation, particularly in key areas such as study design, interpretation of scientific research and presentation of dossiers.
Experience has shown that failure to get these elements right when preparing a dossier invariably leads to a negative opinion from the European Food Safety Authority, raising demand for the expertise of companies such as international scientific and regulatory consulting firm Cantox Health Sciences International.
"Three or four years ago about 20 per cent of our work would have been in relation to efficacy, while probably 80 per cent was in relation to safety submissions," says Nigel Baldwin, the company's senior scientific and regulatory consultant. "Now I would say that 40-50 per cent — and certainly the majority of new business — is in relation to claims."
There are broadly three categories of companies that come to Cantox for help, Baldwin says. "There are the companies that need us to do absolutely everything for them. There are the companies that have done a fair amount themselves and just need us to review the dossier they've written, and need a second opinion. And then there are the companies that might have dug themselves into problems. A number of companies are coming to us in the latter stages of their application process where they've suddenly realised that the EFSA is playing real hardball, and need us to help them." In essence, he adds, "a lot of people pay us to think like the EFSA."
One key aspect of the claims approval process is that the EFSA is looking for high-quality, 'gold-standard' clinical studies — the kind more often associated with medicine — to back up submissions. This has created an attractive business opportunity for contract-research organisations (CROs). This prompted global food-safety-testing specialist Silliker in June to buy France-based CRO Biofortis. Announcing the deal, Silliker said, "Regulations are tightening and food companies need additional expertise and support to prove the effectiveness of their products."
"The EU Nutrition and Health Claims Regulation has certainly had a positive impact on our business," confirms Stéphane Deniau, business manager at Biofortis. "We have experienced an increase in enquiries regarding our services. Many food and dietary-supplement companies are still unsure of how to interpret the rules, causing uncertainty on whether they should conduct clinical trials to communicate the properties and benefits of their products to consumers. The regulation, coupled with the growing popularity of a wide range of functional-food components, will in all likelihood result in greater demands for human clinical studies."
In other areas, too, the regulation is changing how companies approach the market. European ingredients supplier Beneo Group says it has seen a "significant increase" in its workload in relation to developing product concepts that will meet the proposed EU nutrient profiles. These profiles will prevent some products high in salt, sugar and saturated fat from carrying health claims, to stop consumers being misled into buying products they believe are good for them.
"We have seen a shift in thinking as major food producers within the industry begin to look at their product portfolios and analyse the impact that the nutrient profiles will have on them," says Rudy Wouters, head of food application technology at the Beneo Group. "Although the nutrition profiles under development include a two-year adoption period, money and time is being invested now by the major players to ensure that they are ready for a new era of nutrition and health claims."
The experiences of Cantox, Biofortis and Beneo illustrate that despite the intensity of the industry's lobbying efforts, functional-foods and ingredients companies have largely reconciled themselves to adapting to life under the health-claims regulation. But the fact that many have resorted to bringing in outside help to do so also indicates that the regulation will come at a significant financial cost to the industry. Whether such investment will prove to have been in vain rests, ultimately, in the EFSA's hands.