A panel of independent renowned experts in the field of probiotics confirmed the GRAS status for infants and children while Health Canada approved the formula for children from 3 months old.
The expert panel has recognized that both the ProbioKid® formula and individual probiotic strains (Lactobacillus helveticus Rosell®-52, Bifidobacterium infantis Rosell®-33, Bifidobacterium bifidum Rosell®-71) are safe for infants and children, including their use in infant formula, confirming the Generally Recognized as Safe (GRAS) status for this population category.
Canadian authorities had already approved specific heath claim such as “Helps to reinforce the body’s natural defences in children” for infants over 6 months but have now extended those claims for infants over 3 months (NPN 80019993) based on new complementary safety studies.
Solange Henoud, Regulatory Affairs Director, comments: “Not only these achievements are key for the North American markets but they also can be seen as a global recognition of our strains safety in babies, being a vulnerable population. In their opinion report, the scientific experts mentioned that “other qualified and competent scientists reviewing the same publicly available information would reach the same conclusion”.
Bérengère Feuz, Marketing Manager commented: “This recognition from the North American authorities is the validation of our track record of safe use of our ProbioKid® formula as it has been marketed for around 15 years around the world under various local brand names, with great market success stories like in China where it has been the best-selling probiotic formula for children since 2003.”
ProbioKid® benefits from several pre-clinical and clinical studies showing its ability to help balance the immune response (Th1/Th2), to reduce the incidence of infectious episodes in children during winter, and to help support their immune response, probably by favouring immune maturity (Cazzola, 2010; Pantovic 2012). More recently a study showed its effects in controlling the incidence of wheezing and respiratory infections in at-risk children during a 3- month intervention, with persisting effects for up to 9 months after the supplementation (Stojkovic et al. 2016).