Health risk assessment of a food supplement containing Lactobacillus reuteri Protectis
Report no: 2016: 02
The Norwegian Scientific Committee for Food Safety (VKM) has at the request of the Norwegian Food Safety Authority (NFSA) assessed the health risk of probiotics in a food supplement for use by infants and young children. Because of lack of long-term data, it is not possible to answer whether the amount of the food supplement or the age of the infant or young child is of importance.
VKM is not aware of any data indicating that this type of probiotic, Lactobacillus reuteri, has been the cause of serious human diseases, and none of the studies examined has reported any adverse or undesirable short time effects. It has also been used in preterm infants with dosage corresponding to the actual recommended dose, without reporting any adverse, short term reaction.
There is therefore no evidence leading to consider that this probiotic at the recommended dosage, as unsafe.
Unknown long-term effects
More long-term data are still lacking, and the long-term safety for the age groups considered in this assessment cannot be established.
As evidence is accruing that the early microbial composition of the infant gut is important for the development of the gut flora and the immune system of the growing child, it is not possible to exclude that a daily supply of a particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract, may have long-term, albeit still unknown, adverse effects on its development.
As the long term data are lacking, it is not possible to answer whether the amount of the food supplement or the age of the infant or young child is of importance.
If later long-term data should reveal any adverse reaction, it is reasonable to assume that the actual age group will be the most vulnerable.