EFSA issues immune and gut health claim guidance; 'It will be better for all concerned'


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Consultant on the draft consultation: “We do not see any new path to win claims."
Consultant on the draft consultation: “We do not see any new path to win claims."

Related tags Gut health claim Immune system European food safety authority Efsa

EFSA has issued a long-awaited immune and gut health claim guidance document it says draws on years of dossier assessment and includes biomarker updates, but a leading consultant was left unimpressed saying it “does not provide big news”.

European Food Safety Authority (EFSA) spokesperson Jan Op Gen Oorth told us the consultation“uses case history to clarify and make it easier to understand what is required in a dossier”.

“It doesn’t lower the standard but industry will benefit from clearer guidelines and the panel is hoping to receive better applications as a result. It will be better for all concerned.”

But parties close to the health claims process for prebiotics and probiotics and other nutrients, like the German consultancy and contract research organisation (CRO), analyze & realize, said there was little new in the document.

“We do not see any new path to win claims,”​ said the firm’s head of consulting, Annegret Auinger. She noted that while some measures altered somewhat, overall there was little to give industry hope of a prebiotic or probiotic health claim win any time soon.

“Altogether, the draft consultation does not provide big news.”

She noted a downgrading in importance of stool transit time and an increase in importance for ethnic populations.

Parties have until March 23 - six weeks - to submit comments.

EFSA last week also published comments and responses to previous comments that came in following the previous guidance back in 2011.

Comments were submitted by the likes of the Association of the Self-Medication Industry (AESGP), Beneo, Chr Hansen, Danone, DuPont-Danisco, Food Supplements Europe, Mondelez, Morinaga, Nestlé, Sensus, Valio and Yakult. The now amalgamated Global Alliance for Probiotics (GAP), Yogurt Live and Fermented Milk Association (YLFA) and the International Probiotics Association (IPA) also submitted comments.

All those comments and EFSA responses are here.

Industry groups were still considering the document as we went to press.


Affirmed in the consultation were claims considered too general such as: “gut health”,“natural defences”, “strengthen the immune system”, “maintenance of a normal immune system”,“normal development of gut function” ​and “normal digestion”.

The document outlines cases where outcomes can and cannot be measured.

One example was the adhesion of P-fimbriated E. coli​ to uroepithelial cells in vivo​ in humans. Whilst it was deemed to be beneficial, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said it could not accurately be measured with current methods and so discounted it.

probiotics-contains probiotics

Other outcomes which could be measured but may not be relevant to a particular health benefit included:

i) changes in stool pH and short-chain fatty acid production (including butyrate) in the gut;

ii) changes in the composition of the gut microbiota;

iii) changes in the structure of the intestinal epithelium;

iv) changes in markers of inflammation (including markers of chronic, subclinical inflammation), such 347 as interleukins or C-reactive protein;

v) changes in immune markers, e.g. numbers of various lymphoid subpopulations in the circulation, proliferative responses of lymphocytes, phagocytic activity of phagocytes, lytic activity of natural killer cells and cytolytic T cells, production of cellular mediators, serum and secretory immunoglobulin levels, delayed-type hypersensitivity responses, etc.

The NDA stated therapeutic targets such as “a reduction of gastric acid levels”​ or “a reduction of inflammation”​ were disease states and not relevant for the general population.

Excessive intestinal gas accumulation was seen as an example of a beneficial change in a specific function of the body - reducing gastrointestinal discomfort.

On this matter Canadian microbiologist and visiting professor at the University of Guelph, Jason Tetro, PhD, commented: I am still convinced EFSA wishes to follow a pharma-based review process. For example, rejecting normally used biological markers - ie cytokines - as a means of determining benefit is difficult to swallow. Also, the concept of a biological system is ignored; everything has to be measured based on the direct mechanism of the food.”

“Based on this document, it seems EFSA is not interested in this direction, I feel they are simply setting up researchers and companies for failure by continuing to promote vague direction and a lack of commitment to a standardized process for approval.”

Other considered areas included:

  • Claims on reduction of risk factors for infections
  • Claims on a beneficial change in response to allergens
  • Claims on defence against vaginal pathogens
  • Claims on defence against pathogens in the urinary tract
  • Claims on (immune) defence against pathogens and on pathogens in the respiratory tract
  • Claims on (immune) defence against pathogens in the gastro-intestinal tract
  • Claims on digestion and/or absorption of micronutrients
  • Claims on improved lactose digestion
  • Claims on maintenance of normal defecation
  • Claims on gastro-intestinal discomfort in infants and young children
  • Claims on gastro-intestinal discomfort in adults
  • Claims related to essential nutrients compared to non-essential nutrients

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