The sentiment was well-received by an industry seeking better understanding of EFSA’s claim dossier requirements, but its approval came with a “wait and see” caveat, as some wondered how the resource-strapped organisation would deliver on its commitment.
NutraIngredients.com will publish a comprehensive industry response to the meeting in coming days but click here to hear one stakeholder’s take on the day’s events.
Professor Albert Flynn, chair of EFSA’s Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA), which is charged with assessing the 4000+ health claims submitted from across the European Union bloc, emphasised “now is a good time to reflect on what we are doing and get feedback from industry.”
“There should be more communications with applicants,” Professor Flynn said, noting emails and phone calls would form part of increased NDA-applicant dialogue. “This is beneficial for them and it is beneficial for us.”
Much of the guidance industry seeks on claim dossiers is too technical to be produced in a general guidance document and so would be dispensed on a case-by-case basis, he said.
“We will have further consultations because we realise this is a very complicated process,” said Professor Flynn. “We have listened to industry and we know, for instance, that some of the opinions issued by the NDA could be more transparent. We fully intend to be more transparent.”
But Professor Flynn said EFSA’s scientific criteria, which are weighted toward “gold standard” human, clinical trials, remained unchanged. This criteria would continue to be applied similarly to article 13.5 (emerging and proprietary claims) and article 14 (children’s and disease reduction claims) that were the subject of yesterday’s meeting, as well as the 4000-strong article 13.1 generic claims list.
Many in industry regard these criteria as being inappropriate for generic health claims where they are argue more weight should be given to observational, historical and other data.
Professor Flynn acknowledged this. “People feel we are being too strict but we have to weigh the totality of evidence and come to a scientific judgement. We are doing what the regulation asked us to do. People feel there are other ways with less demanding levels of evidence but this is our interpretation of the regulation and this is how we will proceed.”
Another controversial issue under discussion yesterday was claim wording, with some NDA opinions to date hinging on how tightly the wording matched the available science. In some cases it has been apparent the wording, rather than the quality of the science, has been to blame for negative opinions.
The NDA has taken to issuing suggested claims to match science presented in dossiers it deems strong enough, and Professor Flynn gave a nod in the direction of the European Commission and the EU’s 27-member states which are charged with interpreting and authorising EFSA’s opinions, to further this process.
“We issue wording that reflects the science and don’t ask whether consumers understand the wording. Yet the applicant will want to use wording consumers can understand and the Commission may be open to interpretation on this.”
Clock-stop and clarity
EFSA would implement a clock-stop procedure so that opinion timeframes were extended when queries flowed either way between the NDA and applicants.
Such a procedure would help industry produce better dossiers and, in theory, reduce the number of negative opinions.
“We should be able to produce a tight definition of what the claim is so we have a clear view of what we are evaluating,” said Professor Flynn. This had not always been the case with the 60-or-so article 13.5 and 14 dossiers the NDA had already issued opinions on.
Of those dossiers, Flynn said there had been a “wide spectrum” of quality, noting cholesterol-lowering as a particularly strong area; weight management less so.
Industry is calling for a similar summit on article 13.1 claims but no date has yet been established.