In Australia probiotics are well known and well used. We like our Yakult drinks and we can buy other foods that contain probiotics, or swallow capsules full of beneficial bacteria. Australians know probiotics are good for us.
However, if you are a consumer in Europe, though you will find foods with probiotics in them, you will not find the word probiotic on food packs. In fact, one of the major controversies in the European food industry is that EFSA (European Food Safety Authority), the EU body charged with amongst other matters, approving food claims, has rejected 310 claims for probiotics. EFSA has indicated that putting the word “Probiotic” on a food pack is stating a health benefit. So instead, food companies list the relevant bacteria present in the food and leave the interpretation of the presence of these bacteria to the consumer.
When I first read about the 310 rejections I wondered how this number of rejections reconciled with the acceptance of the benefits of probiotics in the rest of the world Everyone knows probiotics work –don’t they? How on earth can EFSA reject all probiotic health claim applications? Headline articles about the success of probiotics supplementation and faecal transplants demonstrate that ingesting specific bacteria can have beneficial effects¹.
One EU food manufacturer has taken their complaint over this rejection, to the European Commission, writing in regards to the EFSA rejection “The absence of qualified scientific evaluation…… is to us highly unsatisfactory ”²
I was intrigued and so decided to investigate, but before reporting on my conclusions I should declare my bias, which is a belief that probiotics are beneficial. Amongst positive results are a 2016 meta analysis which concluded that probiotics could reduce body weight³.
However, IBS McKenzie et al4 concluded : Evidence indicated that no strain or dose specific probiotic was consistently effective to improve any IBS symptoms…”
In contrast, Eamonn Quigley in Journal Clinical Gastroenterology5 writes of probiotics and IBS;
Clinical studies supporting a role for probiotics in the management of IBS predated such experimental data, and randomized controlled trials of probiotics in IBS continue to be reported. Their interpretation is hampered by the less than optimal quality of many studies; nevertheless, it is apparent that probiotics, as a category, do exert significant effects in IBS. Defining the optimal strain, dose, formulation, and duration of therapy is more challenging given the limitations of available data.
In an earlier paper and with co-workers he wrote;
“Of the 42 trials evaluated examining the efficacy of lactic acid bacteria in IBS, 34 reported beneficial effects in at least one of the endpoints or symptoms examined, albeit with tremendous variation in both the magnitude of effect and the choice of outcome under consideration. However, numerous concerns have been expressed over deficits of trial design…”
As is often the case the devil seems to be in the detail. There is in fact good evidence that probiotics as a category are effective. However, the basis of EFSA rejections (and of McKenzie et al cited above) appears to be that there is no consistency with a particular probiotic strain and that EFSA is required to evaluate probiotics in pharmaceutical terms. For example EFSA also requires clinical end-points for the studies using the one strain; rather than markers of say immune activity or changes in the gut microflora, which have been used in some studies to evaluate probiotic effectiveness.
Another perspective is that of M.B Katan who argues that EFSA has made the correct decision in rejecting these proposals and that there was no other option given the EU regulations under which EFSA operates6.
And a number of the applications used studies conducted a number or years ago and therefore do not have the trial design criterial sought by EFSA.
The same issue does not arise with prebiotics in EU, where there are a number of prebiotic-related health claims approved. In part this may reflect the more defined nature of prebiotics.
¹ International Journal of Molecular Sciences 2016, 17:928, MJ. Saez-Lara et al, Nature Biotchnology 2015, 33:787, M. Ratner
³ International Journal of Food Sciences and Nutrition 2016 67: 571-80
4 Journal of Human Nutrition and Dietetics 2016 29:576-592
5 Journal Clinical Gastroenterology 2015 49: S60-64
6 Beneficial Microbes 2012, 3: 85-89