Lallemand Health Solutions’ three probiotic strains L. helveticus Rosell®-52 (R0052), B. infantis Rosell®-33 (R0033) and B. bifidum Rosell®-71 (R0071), have now completed the approval process by the National Health Commission of the People’s Republic of China for use in infant food.
“This endorsement is a prodigious regulatory achievement given the limited number of strains that made it to that elitist list of only 12 strains, including these three.” Commented Solange Henoud, Global Regulatory Affairs Director at Lallemand Health Solutions Inc. “Our team went through a complex and lengthy registration process, but the strong evidence we had on hand for these strains, made us confident we would reach this coveted final stage.” Concluded Mrs. Henoud.
Pivotal safety studies
A randomised, double-blind, placebo-controlled study [Manzano, 2017] confirmed the safety and tolerance of the three probiotic strains L. helveticus Rosell®-52, B. infantis Rosell®-33 and B. bifidum Rosell®-71 in 221 healthy three to twelve month-old infants. The babies were on different diets – formula, mother milk or a combination of both. The post-hoc analysis [De Andres, 2018] showed how these three probiotic strains help support a baby-specific microflora, regardless of any influencing factors.
In a randomised, double-blind, placebo-controlled study [Xiao, 2019] to measure safety and efficacy of the combination of these three probiotic strains and fructo-oligosaccharides (FOS), also known as Probiokid® formula, in 132, three and a half month-old to six month-old healthy, formula-fed babies, scientists concluded that Probiokid® can play a role in gut functions in babies and help support a normal immune development.
Ready for infant formula market
Whether in combination or as single strains, they have also been successfully notified as Generally Recognized as Safe (GRAS) to the United States (US) Food and Drug Administration (FDA) for the specific use in infant formula. The two bifidobacteria strains, B. infantis Rosell®-33 and B. bifidum Rosell®-71, have demonstrated in vitro synergy with human milk oligosaccharides (HMO). Lallemand Health Solutions strains and formulas dedicated to babies are manufactured according to the highest quality standards for infant formula applications, opening new market opportunities in China, US and beyond