Lallemand Health Solutions has received approval from the Brazilian Health Regulatory Agency, ANVISA, for Probiokid for use in infants and children aged from three to 36 months.
Probiokid is a probiotic supplement for children which combines Lallemand Health Solutions’ probiotic strains L helveticus Rosell-52, B bifidum Rosell-71 and B infantis Rosell-33.
These strains have been notified to the US Food and Drug Administration (FDA) as generally recognised as safe (GRAS) from birth for non-exempt infant formula.
They are also listed in China on the very narrow strains list permitted for use in infant food.
The efficacy of Probiokid is supported by data from 28 clinical trials, including two safety trials, conducted in paediatric populations.
Lallemand Health Solutions Regulatory and Compliance vice-president Solange Henoud stated: “We are beyond proud! Our product, supported by decades of scientific, marketing and regulatory accomplishments, has achieved the almost impossible nowadays: getting an approval in Brazil! It is the first one this year.
“It’s been a while since anyone from the industry has made it this far, but with a documented product such as Probiokid, with its extensive marketing journey and various regulatory acknowledgements across the globe for infants and children, we felt confident.
“We hope this approval paves the way for further probiotic approvals to unfold, for the greater benefit of the Brazilian population.”
Probiokid has also received a designation in Canada as healthy for use in children and in babies from the age of three months.