The two probiotic strains were approved for two Canadian health claims regarding the ingredients’ abilities to help formula-fed babies develop a similar microflora as to breast-fed infants.
Lallemand Health Solutions’(Mirabel, Canada) probiotic strains Bifidobacteria infantis Rosell-33, and Bifidobacteria bifidum Rosell-71 were approved for two Canadian health claims regarding the ingredients’ abilities to help formula-fed babies develop a similar microflora as to breast-fed infants.
These claims are:
“The science and work carefully achieved during the past years assessing the safety and beneficial impact of these strains on a baby-specific microflora continue to receive official acknowledgements. This is a huge step in demonstrating that our probiotics can contribute to support normal gut and immune maturation in early life,” said Solange Henoud, vice president of regulatory and compliance at Lallemand Health Solutions, in a press release. “Indeed the U.S. Food and Drug Administration (FDA) had previously formally and publicly endorsed that the usage of these specific strains in infants’ formula is Generally Recognized as Safe (GRAS). An achievement that was followed by several other health authorities, under different jurisdictions, such as the listing by the Chinese authorities and Canadian Food Directorate as a new infant formula ingredient – needless to say that these lists are very narrow and only few specific strains are permitted for such use.”
Among the research supporting these conclusions is a 2017 study which found that Rosell-33 was well tolerated and safe in infants between three and 12 months of age.