The Norwegian Scientific Committee for Food Safety has at the request of the Norwegian Food Safety Authority performed an assessment of infant formula and follow-on formula with Lactobacillus fermentum CECT 5716.
In the assessment of L. fermentum CECT 5716 by the expert committee in EFSA, the panel considered that the strain is sufficiently characterized.
VKM is not aware of any data indicating that this strain has been the cause of human disease.
L. fermentum CECT5716 is fully susceptible to all antibiotics that are recommended EFSA and is considered safe with respect to absence of antimicrobial resistance genes.
The producer refers to two randomized clinical studies in healthy infants of 1-6months of age with respect to possible safety aspects, concluding that the L. fermentum CECT 5716 was well tolerated and safe for the groups examined. However, data concerning safety aspects specifically concerned with new-borns, or for immunocompromised infants are lacking.
The producer has submitted some data regarding possible long-term adverse effects of giving the strain daily as a “monoculture” over a prolonged period of time. These data are not sufficient to draw any conclusion regarding long-term safety of the strain.
It is supposed that the early composition of the human gastro-intestinal tract microbiota can have long-lasting functional effects. If that is the case, a daily supply of a “monoculture” of a single, specific strain such as L. fermentum CECT 5716, in large quantities over a prolonged period of time to age groups where the intestinal flora is still developing may therefore have unknown, but possible long-lasting adverse effects.