Assessment of Infant Formula and Follow-on Formula Supplemented with Lactobacillus fermentum CECT5716
Journal Title: European Journal of Nutrition & Food Safety - Year 2015, Vol 5, Issue 1
Abstract
The Norwegian Scientific Commitee for Food Safety (VKM) has appointed a working group of experts to answer a request from the Norwegian Food Safety Authority regarding risk assessment of Lactobacillus fermentum CECT5716 in infant formula intended for use from birth (0 month) and in infant formulae and follow-on formulae intended for children after the age of 6 month. The mandate of this risk assessment was not to evaluate the health claims related to the products as such health claims are assessed by EFSA. However, in the EFSA opinions so far (November 2009), a cause and effect relationship has not been established between the consumption of L. fermentum CECT5716 containing products and the claimed effects. In the assessment of L. fermentum CECT5716 by the expert committee in EFSA, the panel considered that the strain is sufficiently characterized. We are not aware of any data indicating that this strain has been the cause of human disease. Its potential toxicity and ability to translocate has been studied in adult mice after oral administration of doses 10 000 times greater than those normally consumed by humans without observing any bacteremia or translocation to spleen or liver. However, strains of Lactobacillus have from time to time been isolated from human blood cultures and may therefore, although seldom, translocate. L. fermentum CECT5716 is fully susceptible to all antibiotics that are recommended by the Panel on additive and products or substances used in animal feed (FEEDAP) of EFSA and is considered safe with respect to absence of antimicrobial resistance genes. DNA-sequence data do not imply the presence of any gene(s) coding for toxin production, but confirming in vitro-studies are missing. The FBO 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 CECT5716 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 FBO 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.
Authors and Affiliations
Jørgen Lassen, Siamak Yazdankhah, Judith Narvhus
Keywords
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- EP ID EP350370
- DOI 10.9734/EJNFS/2015/14817
- Views 97
- Downloads 0
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