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What is a health benefit? Researchers issue probiotic guidance for EFSA applications

Posted:  Monday, September 16, 2013

An evaluation of all EFSA opinions relating to probiotics will help industry players better understand what sort of claims are accepted as a health benefit and which claims are not, say researchers. Writing in Beneficial Microbes, the research team analysed opinions on probiotic health claims from the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA panel) published between 2005 and 2013 “to provide an overview on what grounds certain health effects were accepted as beneficial and others not.”

Led by Profile Ger Rijkers from the University College Roosevelt, Netherlands, the authors noted that all opinions from the NDA Panel distinguish claims that are definitely beneficial, possibly beneficial or non-beneficial to human health.

“A number of statements were found to be consistently used by the EFSA to indicate beneficial health effects; statements regarding both maintenance of normal or (physically) healthy physiological states and improvement or reduction of unhealthy/pathological ones,” said the authors.

“Overall, 78% of all analysed health claims are considered by the NDA Panel as (possibly) beneficial to human health, in particular the gut health effects.”

However, they noted that in many cases, the scientific substantiation of these particular health claims were deemed insufficient - meaning applications were turned down.

“For future health claim applications concerning probiotics to be successful, they should include specific statements on what exactly the microorganism affects, and the scientific substantiation of the particular health claim should be based on the targeted (general) population,” the team recommended.

According to the International Probiotics Association (IPA) director general Ioannis Misopoulos, and the IPA Scientific Advisory Board, the study shows what health targets, with relevance to probiotics, EFSA has considered to beneficial and which ones EFSA considers to be possibly beneficial or not beneficial.

Clear targets are suggested for intestinal and immune health; gut microbiota targets are, at best possibly beneficial," said the IPA - who funded the research. This provides an excellent tool for industry and researchers alike on what targets to focus on, and what not, when working on documenting a health claim for EFSA”.

Beneficial effects?

Overall, Rijkers and his colleagues found that 22% of the evaluated health claim applications were made for effects to be considered non-beneficial to human health, with most of these claims relating to changes in the composition of gut microbiota.

“For the other 78%, the claimed effect was considered to be beneficial or possible beneficial,” the authors stated.

By comparing all statements found in the EFSA health claim applications referring to probiotics, the team are also able to reveal that there were no large irregularities or contradictions within and between the NDA Panel statements that determined where claims fell in to these three different categories.

“For instance, all 24 times a decrease in pathogenic (intestinal) microorganisms was mentioned, it was evaluated as possibly beneficial to human health, never as a definitely beneficial effect, nor as non-beneficial.”

“Interestingly, however, while the EFSA considers 'defence against' pathogenic microorganisms to be a beneficial effect, `decreasing the number of pathogenic microorganisms only 'may be' a beneficial health effect,” explained Rijkers and his colleagues. “Considering that `defence against' pathogens should lead to a decrease in their numbers, it could be debated what exactly is the difference between these two health claims.”

Analysis results

The team revealed that claim applications relating to the following health benefits were classed as ‘beneficial’ or ‘possibly beneficial’:

• Maintaining the balance of intestinal microbiota in the context of decreasing (potentially) pathogenic (gastro-)intestinal (micro)organisms
• Changes/improvements in bowel function/regularity (provided they do not result in diarrhoea)
• Maintaining normal bowel function - with reduced (or maintained normal) intestinal transit, and increased bowel movements' frequency (within a normal range)
• Normal blood concentrations of triglycerides
• Reduction of post-prandial glycaemic responses
• An increase in magnesium and/or calcium absorption, with consequent improved calcium/magnesium retention
• Reducing levels of markers of inflammation (under certain circumstances)
• Increase in satiety leading to a reduction in energy intake (if sustained)
• Maintaining individual intestinal microbiota in subjects receiving antibiotic treatment
• Improvement of iron absorption
• Improving of oral health by reducing the number of Streptococcus mutans and by reducing the gingival and plaque indices
• Reducing tooth demineralisation in the context of reducing the risk of caries

Health claim statements considered as a 'non-benefit' were:

• Increasing the number of any groups of microorganisms
• Changes in short chain fatty acid production, or pH in the gastro-intestinal tract
• Increasing IL-10 production by peripheral blood cells or natural killer cells (and enhancing their lytic activities)
• Changes in / reduction of markers of inflammation (such as various interleukins)
• Stimulation of various immunological responses
• Reduction in numbers of circulating CD34+ cells

Claims guidance

In addition to listing claims that have already been assessed by EFSA, the team note that when defining 'health' and 'health claims', applicants must account for the relativity of any such definition.

“A psychological or physical 'improvement' for one person may be harmful to another, any particular risk reduction for one disease can be harmful when considering the course of a different disease,” they explained. “For instance, a reduction in platelet aggregation is beneficial for individuals with a thrombotic tendency, yet harmful for people with a tendency to bleed.”

The researchers also noted that while a wealth of scientific literature shows that products containing probiotics have been widely established as products with a beneficial or improving effect on human health, “still, regulatory authorities, such as the EFSA, collectively express negative opinions on health claims referring to probiotics.”

“How is this possible? Apparently, notwithstanding the body of information in this field, the specific applications for health claims were not providing sufficient evidence for that specific microorganism in the context of the claim made,” they said.

“For a specific claim, the measurable parameters should reflect a truly beneficial effect.”

“Future health claim applications advocating beneficial health effects for certain probiotics should contain specific statements indicating what exactly the microorganisms target,” the authors recommended. “Additionally, the scientific substantiation of the particular health claim should be based on the target population.”

Beneficial MicrobesPublished online ahead of print “What is a health benefit? An evaluation of EFSA opinions on health benefits with reference to probiotics” Authors: K.H. Binnendijk, G.T. Rijkers

For study details:-Click Here!