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China health authorities’ acknowledge L. helveticus Rosell®-52, B. infantis Rosell®-33 and B. bifidum Rosell®-71 for safe use in infant formula

China health authorities’ acknowledge L. helveticus Rosell®-52, B. infantis Rosell®-33 and B. bifidum Rosell®-71 for safe use in infant formula

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

Probiokid® , the combination of L. helveticus Rosell®-52, B. infantis Rosell®-33 and B. bifidum Rosell®-71  and FOS, is one of the most documented probiotic formula with 11 clinical studies in infants and young children. It has been granted the following Canadian health claims: helps to reinforce the body’s natural defenses and participates to the microflora balance in children; could promote a favourable gut flora and is a source of probiotics from three months old babies, up to older children.

Quality probiotics. Complete solutions.

Founded in 1934, Lallemand Health Solutions is a vertically integrated probiotic manufacturer specializing in the research, development and manufacturing of ready-to-market and custom probiotic formulations. Its products target specific populations and health segments including babies’ health, gut health, natural defenses, women’s health, brain-gut axis, skin health, metabolism, oral health and sport. Probiotics are produced in cutting-edge plants certified to the highest quality standards. More than 600 probiotic formulas are currently marketed in over 60 countries across five continents. From lab to shelf, Lallemand Health Solutions has the full control and expertise to produce premium probiotic solutions, blends and custom formulations as each development step is expertly supported by internal quality insurance, regulatory affairs, research and development, scientific affairs, technical support, sales and marketing teams.

Scientific cooperation spells success

The Rosell® Institute for Microbiome and Probiotics by Lallemand,  Lallemand Health Solutions’ research and development center located at the National Research Council of Canada in Montreal, develops partnerships with key scientific experts in order to  study the human microbiome and how probiotic supplements can be used as a mean to improve or maintain health in specific populations or health segments. The research team has published over 330 publications including 160 clinical studies.

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Marilou Luneau, Content manager, Lallemand Health Solutions

Published Jun 7, 2020 | Updated Jan 11, 2024