Professor Ambroise Martin, chairman of the European Food Safety Authority (EFSA) health claims panel, conceded there had been a huge shift in the context and processes for health claim approvals. But food firms had to follow the stringent, science-based criteria to be successful, he added.
Addressing delegates at the Vitafoods conference in Geneva, Martin said: “[Previously] you could test many outcomes in the same scientific study and make a claim on the positive one. Now you have to design the study to the proposed claim. These regulations are not so new now but it does change the context and I am not surprised that some claims that were allowed are not any longer.”
Reflecting on why so many claims had been unsuccessful – a huge bone of contention for many in the industry who argue the process is too rigid and convoluted – Martin said all too often two of the three pre-requisites for a positive outcome were neglected.
Fit for purpose
While many of the dossiers submitted focused heavily on seeking to substantiate the health claim, they did so at the expense of adequately characterising the food and the subsequent effect of that characterisation, he told delegates.
In his keynote address, Martin added: “[Detailed] food characterisation is vital to check that the studies used are pertinent for claim substantiation. We can reflect on very nice papers published in very good journals but [that is not sufficient] if they do not adequately characterise the food in relation to the commercial objective. Imprecise food characterisation can stop the approval process very quickly.”
A further problem that frequently came to light was shortcomings in proving the effect of the characterisation in a scientific manner.
Martin said there was “no problem” in proposing new effects on health, but that it had to be precisely determined by the applicant if it was not yet accepted by the panel.
“You must define a scientifically evaluable claim – not a consumer-friendly claim, that is not the issue,” he said. “We make a scientific judgement on whether the clinical effect is found to be beneficial or not.”
Even though many health claim dossiers focused on the third strand of claim substantiation, this by no means meant that they were always adequately populated with enough information to get a positive approval, even if the first two strands were suitably covered.
Giving advice to applicants, Martin added: “We need to know the literature search strategy and the hierarchy of evidence so we can scientifically evaluate each provided study to see if its conclusion could be limited or if no conclusion can be drawn to prove a cause and effect relationship.”
In relation to the type of studies, Martin said an absence of human studies would lead to a negative opinion, but supportive studies could be of any type.
While admitting that the health claim issue was “very complex”, Martin added it was essential to provide a science-based regulatory process for the industry across Europe.