Lallemand gets Health Canada approval for infant probiotic strains

By Danielle Masterson

- Last updated on GMT

Getty Images / Delmaine Donson
Getty Images / Delmaine Donson

Related tags b. infantis Lallemand infant microbiome Probiotic

This is the first time that Health Canada has recognized probiotics can balance formula-fed baby’s microflora similar to breastfed infants.

Two of Lallemand Health Solutions’ probiotic strains were approved for two Canadian health claims, paving the way for the strains to be marketed as helping babies develop a similar gut microflora as breast-fed infants.

These claims for Bifidobacteria infantis Rosell-33 and Bifidobacteria bifidum Rosell-71 include: 

  • Helps to maintain a baby-like microflora in infants (for formula-fed infants
  • Helps to balance formula-fed baby’s microflora similar to breast-fed infants


At the heart of this health claim are two studies. The first is a randomized, double-blind, placebo-controlled study​, where B. infantis ​Rosell-33 was deemed safe and well-tolerated in 221 healthy 3 to 12-month-old infants.

A post-hoc analysis​, based on a sample of infants from the Manzano 2017 study, showed B. infantis ​Rosell-33 can maintain a baby-specific microbiome profile rich in bacteria able to digest lactose such as Bifidobacteria, regardless of any influencing factors such as diets, birth mode, etc.

On the other hand, the placebo group showed a significant increase in common constituents of healthy adult gut microbiota, and a decrease of Bifidobacteria. Additionally, the anti-inflammatory IL-10/IL-12 ratio increased during the eight week period of intake, while the placebo group turned toward a more pro-inflammatory state.

"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, Regulatory and Compliance at Lallemand Health Solutions. 

“A strong differentiating feature”

Both strains can be formulated in adapted galenic formats such as sachets, sticks and drops or in raw powder to be added directly in infant formulas. 

“The industry is showing a strong interest in developing the most nutritious infant formula with exclusive ingredients that meet all the requirements for this specific target market. Given the limited numbers of recognized strains suitable for infant formula, probiotics can be a strong differentiating feature and opens the door for the baby probiotic category,”​ said Henoud.

Henoud added that since both Bifidobacteria infantis Rosell-33 and Bifidobacteria bifidum Rosell-71 were previously recognized as GRAS, it is possible to add them as a direct probiotic in infant formula or to pour directly probiotic powder into baby bottle. 

Parental awareness 

“Parents’ understanding of the role of the microbiota in early life to promote a timely gut and immune maturation is increasing. This awareness of the important role of the gut microbiome even goes beyond the gut,”​ Henoud told NutraIngredients-USA. 

Unicef’s ‘Early Moments Matter’ report found that parents are increasingly aware of the importance of the first 1,000 days of life and how they can help build a child’s future, from brain development to immunity, or even happiness.

And according to FMCG Guru’s 2021 Early Life Nutrition Questionnaire, over 42% of parents reported aiming to obtain probiotics for their child. This positions probiotics behind protein, but before omega 3 in the nutritional supplements space.

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