The rejected strains submitted to the European Food Safety Authority (EFSA) under article 13.1 of the EU nutrition and health claims regulation (NHCR) were:
- Lactobacillus crispatus BCCM/LMG P-17631 (ID1030, 2950)
- Lactobacillus gasseri BCCM/LMG P-17632 (ID 2956)
- Lactobacillus gasseri BCCM/LMG P-18137 (ID 2957, 2958)
- Lactobacillus paracasei CNCM I-1687 (ID 2960, 2961)
- Lactobacillus paracasei CNCM I-1688 (ID 2962, 2963)
- Lactobacillus plantarum BCCM/LMG P-17630 (ID 2966, 2967)
- Lactobacillus salivarius CNCM I-1794 (ID 2970, 2971)
- A blend of Bifidobacterium animalis ssp. lactis Bf-6 and Lactobacillus johnsonii La-1 (ACD-1)(CLbA22) (ID 4231)
Perhaps most intriguingly, a claim that some of the above probiotic strains (2960, 2962, 2971) could increase IL-10 production and/or enhance the activity of natural killer cells was turned down primarily because it was not deemed a beneficial effect.
“The Panel notes that increasing IL-10 production and/or enhancing the activity of natural killer cells is not a beneficial physiological effect per se, but needs to be linked to a beneficial physiological or clinical outcome,” said EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA).
That hadn’t been done, so the claim was rejected.
For many of the submitted strains’ ability to reduce gastro-intestinal discomfort, the NDA said there were no intervention trials, “from which conclusions could be drawn for the scientific substantiation of the claim.”
For decreases in potentially pathogenic gastro-intestinal microorganisms the result was the same: No reliable intervention studies for the selected strains.
Improved lactose digestion for individuals with lactose maldigestion was similarly rejected.
‘Intestinal flora/digestive health’ was considered too general and non-specific a claim to be permissible under the NHCR.
Defence against vaginal pathogens was not backed by human intervention studies.
The NDA opinion can be found here.