EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) has pooled these and other observations from the 200+ gut health and immunity opinions it has already published into a guidance document interested parties can respond to over the next three weeks.
Key points of clarification from the NDA include:
- Improved digestion or absorption of nutrients such as lactose and iron are physiological beneficial and can form the basis of claims.
- Maintenance of a normal immune function is physiologically beneficial but the effect must be defined in a way such as ‘defends against pathogens/allergens’. ‘Boosts natural defences’ claims are not specific enough.
- Reduction in the incidence of respiratory, gastrointestinal and urinary infections are valid outcome measures for general immunity claims if matched by changes in immunological parameters such as a reduction in allergens or pathogens.
- Self reported allergy data is, “unreliable and insufficient for diagnosis of allergy.” Clinical and lab measures should be shown in the same intervention studies.
- Reductions in inflammation markers can be beneficial.
The NDA noted a number of pathogens that require no further characterization and whose reduction could form the basis of a claim including Salmonella, Campylobacter, Listeria, some Escherichia coli strains, Yersinia, Shigella and toxin producing bacteria such as Staphylococcus aureus, Clostridium botulinum and Bacillus cereus.
Others included Vibrio vulnifucus/parahaemolyticus, rotavirus, noroviruses, verotoxigenic E. coli, Enterobacter sakazakii, toxigenic C. perfringens (type A and B), Echinococcus, Toxoplasma and Giardia, Helicobacter pylori, Clostridium difficile and Clostridium tetani.
“For claims related to maintaining normal defence against pathogens in the gastrointestinal tract, appropriate outcome measures could include reduction of numbers of pathogenic microorganisms or their toxins in suitable samples as well as clinical outcomes (e.g. number and duration of episodes of infection, severity of symptoms, duration of infection, e.g. as measured by infection-related diarrhoea), demonstrated in human intervention studies,” the NDA wrote.
Intestinal permeability, production of short chain fatty acids and pH changes are deemed valuable only as supportive evidence.
Similarly, the NDA pointed out that immune function biomarkers such as levels of lymphoid subpopulations; responses of lymphocytes; phagocytic activity of phagocytes; lytic activity of natural killer cells and cytolytic T cells; production of cellular mediators; immunoglobulin levels and delayed-type hypersensitivity responses only had value as supportive evidence. Alone such markers would not validate claims.
Studies performed on diseased populations such as those suffering from Irritable Bowel Syndrome (IBS) could be extrapolated to healthy populations.
Bowel function measures including longer transit time, less frequent bowel movements, reduced faecal bulk and harder stools could be considered beneficial measures of gastrointestinal discomfort.
The draft guidance, which can be found here, and the three-week public consultation will be discussed at EFSA’s gut health and immunity workshop in Amsterdam on December 2, the day after NutraIngredients hosts its second health claims conference in Brussels on December 1.
Details of EFSA’s workshop can be found here.
Click here for details about the second NutraIngredients health claims conference.