EFSA gut guidance is ‘flawed’ says top UK professor
Speaking at Yakult UK’s probiotic symposium in London , Professor Bob Rastall, head of the department of food sciences at the University of Reading told delegates that “the problem we have with probiotics is that EFSA doesn’t seem to like them.”
And discussing applications for probiotics in fields such as clinical medicine or skincare, he said: “If EFSA does manage to kill off the functional probiotic food industry in Europe, it’s nice to know probiotics will have a future in other areas.”
EFSA released a September 30 guidance document on submitting gut health/immunity health claims, concurrently initiating a three-week consultation period during which stakeholders have been invited to respond ahead of a specific workshop in Amsterdam on December 2.
The document states that microbiota introduced to the gut, such as lactobacilli and/or bifidobacteria, must show significant reductions in pathogens or toxinogenic micro-organisms, to back disease risk reduction and general immune function claims.
Said Rastall:“EFSA has recently published some guidance over what kind of studies might be acceptable in gut health area. Its microbiological guidance is, I think, flawed but at least it is holding a public consultation.”
Guidance lacks ‘biological justification’
Asked by NutraIngredients.com at a later panel discussion what he thought was wrong with the guidance, Rastall said:“EFSA has produced guidance over what they consider to be appropriate end-point measures for interventions, one of which is a 1-log decrease in specific gut pathogens.
“There’s many issues with that. They’ve come up with a list of pathogens – some of them acute – that cause disease in very small numbers.”
“These can also be carried by by people without showing symptoms, some are indigenous microbes that can produce toxins under certain circumstances and can overgrow in certain circumstances – C-difficile [clostridium difficile] springs to mind.
“So the idea that you can have a 1-log reduction in a certain pathogen as a health outcome for a functional food intervention just doesn’t really make a lot of sense.
“I just don’t really understand where this came from, and what I am really disappointed about is that the guidance doesn’t really provide any kind of biological justification.”
Peer review process ‘undermined’
Rastall also said that media mis-reporting on failed probiotic health claims, along with associated mistaken media claims that probiotics didn't work per se, rather than strains ill-suited for a specific purpose, had been “hugely damaging for the industry”.
He said:“The point to take home is that this ['probiotics don't work'] is not what EFSA said. The majority of claims were rejected because they did not have enough information to fully characterise the strain in question.
“EFSA I think it’s fair to say are still evolving the rules and they’re really behind the game when it comes to working out what people should do.
“They’ve also been incredibly harsh on certain studies, to the extent of questioning the clinical judgement of authors of papers in published journals, and thus undermining the peer review process.”
Health claims conference
These matters and more will be discussed at the second NutraIngredients Health Claims 2010 conference to be held in Brussels on December 1.
The conference will deconstruct the latest article 13.1 claim opinions, hear first-hand experience from players like Kellogg’s, outline regulation-coping marketing strategies, and feature comparison with the US claims system from leading industry figure, Dr Andrew Shao.
For more details click here.
