Digestive health: target the stomach

Key points​

• The response to EFSA guidance ​​
• Full approval for inulin fibre​​
• Progress in personalised nutrition​​

This time last year it seemed that things were looking up for the beleaguered gut health sector in Europe.

Beneo was the first to buck the negative trend by winning a positive opinion from the European Food Safety Authority (EFSA) for the ability of its prebiotic inulin fibre to increase stool frequency.

Around this time, new guidance from EFSA sought to clarify what must be included in scientific dossiers for other applicants to succeed, raising hopes for other industry players.

And then the probiotics lobby announced it was working on a scheme to make Italy the first Member State to redefine probiotic as a ‘generic descriptor’, rather than a health claim, enabling its reappearance on product labels.

Twelve months on, however, it seems that any progress has once again stalled. The term ‘probiotic’ remains off the labelling menu for now; the EFSA’s guidance drew criticism for its lack of clarity; and prebiotic inulin fibre has yet to be seen as a health claim on a product.

Despite all of this, hopes remain that fortunes will improve over the next few months.

The strategy of arguing for ‘generic descriptor’ status for probiotics, while still a possibility, has fallen out of favour because the consensus is that a harmonised European solution would be preferable to a state-by-state approach (the ‘generic descriptor’ case can only be made on a state-by-state basis for technical and legal reasons).

A harmonised solution based on generic descriptors would require each Member State to submit the same application separately to the Commission.

Instead, a group of Member States including the UK and Italy is attempting to have ‘contains probiotics’ reassigned as a nutrition claim, rather than a health claim. This would put it on the same footing as claims such as ‘low sugar’ or ‘high fibre’.

“It doesn’t prevent us submitting applications to EFSA for health claims, but they would be strain-specific,”​ explains Carine Lambert, executive director at International Probiotics Association (IPA) Europe.

“But for the simple use of ‘probiotic’, without mentioning the strain of bacteria or a specific health effect, it would be a nutrition claim.”​

The Commission and Member States indicated that they were “neutral or positive”​ to this approach at a meeting in February, Lambert says. Now, IPA Europe plans to come up with detailed proposals – such as how much live bacteria would need to be present to make a valid claim and what information consumers would need – ahead of a meeting with DG Santé, the Commission’s directorate general for health and food safety.

The response to EFSA guidance (return to top)​​

The response to last year’s draft guidance from EFSA on preparing a scientific dossier was judged helpful as far as it went, but was criticised for failing to deliver a point-by-point recipe setting out the standards of evidence required for success. In response, and after consultation, EFSA published revised guidance in January, releasing one document covering health claims in general and another targeting gut health.

According to Valeriu Curtui, head of EFSA’s Nutrition Unit, the updated guidance documents will give applicants a better understanding of the step-by-step approach, and help them to “decide what type of claim they wish to submit given the data available to them”​.

A look at the record of approvals shows an extremely high attrition rate for applications under Articles 13.5 (new function claims) and 14 (disease risk reduction or related to children) of the Nutrition and Health Claims Regulation (NHCR).

Of the 155 claims relevant to digestive health as of July 2015, 90 were withdrawn during the evaluation phase, 58 completed the entire process and seven remained under evaluation. Of these, zinc and vitamin D won claims as essential nutrients that support immune function; chicory inulin, sugar beet fibre and hydroxyanthracene derivatives won claims relating to bowel function; while vitamin C won for its ability to support the absorption of micronutrients.

The revised guidance, therefore, aims to lay bare the winning formula, with a detailed explanation of each step of the evaluation process – illustrated with concrete examples from previous evaluations.

“Sure it will be helpful,”​ says Anke Sentko, vice-president of regulatory affairs and nutrition communication at Beneo. As one of the few winners so far under NHCR, Beneo understands more than most what is required.

“It is more visible what you need to do in research and what parameters you need to ​[consider] to make a claim successful in the EU,”​ says Sentko. “It’s important how you do the research and with whom you do the research, because the researchers need to understand the requirements of EFSA and look for the right biomarkers.”​

Full approval for inulin fibre (return to top)​​​

Although there are no prebiotic inulin fibre products on shelves at the time of writing, the news from Beneo remains good, with the positive opinion from EFSA now translated into full approval and products able to carry a corresponding health claim from the start of this year.

“It’s a little early to expect products on shelves,”​ says Sentko, explaining that many companies were waiting to ramp up the development effort until the European decision was finalised.

‘Increases stool frequency’ may not sound like an especially thrilling claim, but Sentko is certain that such basic benefits can be winners with consumers. “It’s something that’s closely related to wellbeing,” she says.

DSM, another winner with its Oatwell beta-glucan, adds that there is a certain degree of flexibility in the wording of such claims, provided the meaning remains the same. “A product with OatWell beta-glucan can be positioned as ‘for good digestion’or ‘for healthy digestion’. The positioning can be achieved by using the official wording of the claim on the packaging. The official wording of the claim is ‘oat grain fibre contributes to an increase in faecal bulk’,”​ DSM says.

Practical progress may be slow, but research continues apace and the predictions are that, sooner or later, gut health and its impact on a wide range of health developments will be huge. In February, the Probiota meeting in Amsterdam highlighted several major areas of interest.

Progress in personalised nutrition (return to top)​​

Clinical-Micobiomics showed recent progress in personalised nutrition based on an individual’s gut microbiome. A study published in Cell last year found that the glycaemic response of 800 people to a range of different foods varied significantly depending on the genetic make-up of each subject’s microbiome.

The researchers built a model to predict which foods would generate an unhealthy spike in blood sugar for particular individuals, based on their gut population. They then successfully turned that into personalised recommendations for healthy diets.

Work is continuing in this vein, with researchers at the Weizmann Institute of Science in Israel currently recruiting subjects to see if this approach can be used to personalise weight management programmes.

Infant nutrition was also in the spotlight, with Evolve Biosystems presenting evidence that using prebiotics to increase the dominance of Bifidobacterium longum subspecies infantis in the infant microbiome could reduce not only gut problems but also asthma, obesity and food intolerance.

The thinking is that the infant microbiome evolved to be dominated by this specific strain, but modern interventions such as antibiotics, formula feeding and caesarean sections have upset that balance.

So, rather than advocating a general probiotic boost, Evolve Biosystems is focusing on finding the complex carbohydrates that favour precisely the right bacteria.