EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to the substantiation of health claims related to various and reduction of gastrointestinal discomfort (ID 1030, 2956, 2958, 2961, 2963, 2966, 2970), decreasing potentially pathogenic gastro-intestinal microorganisms (ID 1030, 2956, 2958, 2961, 2963, 2966, 2970), improved lactose digestion (ID 1030, 2956, 2958, 2961, 2963, 2966, 2970), “intestinal flora/digestive health” (ID 4231), defence against vaginal pathogens (ID 2950, 2957, 2967) and increasing IL-10 production and/or enhancing the activity of natural killer cells (ID 2960, 2962, 2971) (further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006
In the EFSA Journal, 2012
Abstract
Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on health claims pursuant to Article 13 of Regulation (EC) No 1924/2006 in the framework of further assessment related to various microorganisms and reduction of gastro-intestinal discomfort, decreasing potentially pathogenic gastro-intestinal microorganisms, improved lactose digestion, “intestinal flora/digestive health”, defence against vaginal pathogens and increasing IL-10 production and/or enhancing the activity of natural killer cells. The food constituents Lactobacillus crispatus BCCM/LMG P-17631, Lactobacillus gasseri BCCM/LMG P-17632, Lactobacillus gasseri BCCM/LMG P-18137, Lactobacillus paracasei CNCM I-1687, Lactobacillus paracasei CNCM I-1688, Lactobacillus plantarum BCCM/LMG P-17630, Lactobacillus salivarius CNCM I-1794 and a combination of Bifidobacterium animalis ssp. lactis Bf-6 and Lactobacillus johnsonii La-1 (ACD-1)(CLbA22) are sufficiently characterised. The evidence provided did not establish that the proposed claimed effect, increasing IL-10 production and/or enhancing the activity of natural killer cells, is a beneficial physiological effect. The claimed effect “intestinal flora/digestive health” is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006. The references provided in relation to the claims evaluated in this opinion included studies which assessed the effects of food constituents other than the food constituents which are the subject of the claims and/or investigated health outcomes unrelated to the claimed effects. No human studies which investigated the effects of the food constituents on appropriate measures of the claimed effects were provided. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of the food constituents and the claimed effects evaluated in this opinion.