It is currently not possible for a prospective health claim applicant to have an interactive dialogue with EFSA, ahead of the submission of a new health claims dossier. The guidance notes available from EFSA are also of limited value at the relatively early stage in the new health claims regulations. In this scenario, the best source of information is often contained in the published scientific opinions of EFSA’s NDA Panel.
The recent approval of Lactitol (DuPont Nutrition BioSciences Aps) for a health claim of “maintains normal defecation” is a good example (www.efsa.europa.eu/en/efsajournal/pub/4252).
An application containing a relatively large number of human intervention studies, like this one from DuPont, can succeed even when not all of the studies show a statistically significant result and where there are some methodological failings in individual studies. Providing the overall quality of the studies is acceptable there is a “weighting” of the evidence that comes from having a larger dataset. It has been very clear, from earlier EFSA opinions, that companies that submit with just a 2, 3 or even 4 human intervention studies are fatally harmed by a “failed” study or a design/implementation flaw in one of those studies.
Although there was no individual dose response study in the DuPont submission, the applicant effectively demonstrated an element of dose response through a set of studies that used varying doses of between 10 – 50g per day.
Of course the majority of claimants don’t have the luxury of having 12-15 human intervention studies in their submission and if that is the case then you must ensure that there are no substantial methodological mistakes and that all the studies deliver a positive outcome.